Qureos Mentor

ADMA Biologics

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Trainer!
</p></div></div></div></div><div><div><div><div>Job Title: Trainer
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>The <b>Trainer </b>develops, implements, administers and continuously improves the training program for ADMA Biologics. Ensuring that the training program is fully implemented at all levels of the organization.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><ul><li>Promotes a culture of quality and operational excellence and ensures the advancement of the company&rsquo;s Mission and Values.
</li><li>Utilizes adult learning principles to design, create and develop learning solutions to meet learning objectives and accommodates a variety of learning styles.
</li><li>Deliver engaging learning solutions that produce the desired outcomes in responding to the learners needs.
</li><li>Assist in creating, scheduling, and facilitating training the centralized site-wide cGMP training program for all Boca Raton cGMP staff.
</li><li>Develops and facilitates training and development, learning initiatives, and training curriculum for specific roles and departments.
</li><li>Conduct New Hire Orientation training.
</li><li>Reviews and improves standard operating procedures and training programs used throughout the Company. Assists other functional areas in developing training materials associated with departmental SOPs.
</li><li>Participate in development of training metrics to maintain compliance.
</li><li>Provides feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
</li><li>Oversee job-specific departmental training to ensure program appropriateness and compliance. Assesses programs for effectiveness and initiate improvement plans where necessary.
</li><li>Assists in entering training information into the electronic quality management system.
</li><li>Assists, as needed, in processing training records, materials and assignments.
</li><li>Coordinates and performs any additional activities or projects assigned.
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Ability to train and motivate employees at all levels within an organization Knowledge of all Federal and State regulations including OSHA and CUA
</div><div>Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures
</div><div>Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management
</div><div>Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project)
</div><div>Must be able to read, understand, and implement programs based on technical regulations and manuals
</div><div>Must be project oriented, creative, and computer literate
</div><div>Must have excellent writing and oral skills
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements
</b></h2></div><div><p>Minimum of 2 years of experience in Manufacturing, Compliance, Quality Assurance or Quality Control, with at least one year leading training initiatives and continuous improvement in a regulated environment is required.<br>
</p><p></p><p><b>Education Requirements:
</b></p><p>Bachelor's degree is required.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div></div></div></div></div></div></div><div></div><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Trainer

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Technician, Industrial HVAC.
</p></div></div></div></div><div><div><div><div>Job Title: Technician, Industrial HVAC
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>This position has the responsibility to ensure the proper operation and maintenance of all facility HVAC systems and equipment. Take corrective action and repair equipment, as necessary. Provide appropriate notification and documentation of all work performed. Daily activities will include performing HVAC PMs, troubleshooting systems, mechanical and electrical repairs related to HVAC systems and other tasks involving various operations and repairs within a cGMP manufacturing facility.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><p>Responsible for the proper operation and maintenance of all facility HVAC systems, high-capacity chillers, ultra-low refrigeration systems, cooling towers, and liquid pumping systems.
</p><p>Responds to emergencies as requested utilizing resources to effectively repair and ensure the safety and availability of ADMA systems and equipment.
</p><p>Ability to maintain, troubleshoot, and repair package units including large tonnage systems.
</p><p>Ability to maintain, troubleshoot, and repair split systems including large split systems, built up systems, water source heat pump equipment.
</p><p>Ability to maintain, program, troubleshoot, and repair commercial chiller cooling systems and chilled water pumps.
</p><p>Ability to maintain, program, troubleshoot, and repair VFDs in various applications.
</p><p>Ability to trace out and troubleshoot complex electrical systems.
</p><p>Ability to maintain, troubleshoot, and repair specialized systems such as Daikin, Vilter, and Dunham Bush screw compressor systems.
</p><p>Ability to maintain, troubleshoot, install cooling tower motors, fans, and pumps.
</p><p>Perform complex troubleshooting and repair of HVAC systems ensuring the facility stays within a cGMP state.
</p><p>Provide technical assistance for investigations when equipment or system failure occurs.
</p><p>Oversee technical repairs performed by outside contractors on HVAC or related equipment.
</p><p>Research codes and existing ADMA procedures for conformance to regulatory codes.
</p><p>Ensure outside vendors and contractors are trained in applicable ADMA procedures regarding safety, environmental, and health. They must also be monitored to comply with all ordinances such as HVAC and construction codes.
</p><p>Ensure the plant is clean and free of debris or clutter.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Ability to read and understand blueprints
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements
</b></h2></div><div><p><b>Education Requirements: </b>High school diploma or equivalent is required. A minimum of two years of technical or vocational training is required. Equivalent experience (two years HVAC work) may be substituted for technical/vocational experience.
</p><p><b>Experience Requirements: </b>10 years of previous HVAC work in a manufacturing or commercial environment is required. Working knowledge of local, state, and other HVAC codes is required.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div><div><p>Experience with BMS (Building Management Systems) is preferred.
</p><p>Demonstrated experience/proficiency/knowledge/training in a regulated cGMP (FDA, EPA, etc.), manufacturing, or pharmaceuticals environment preferred.
</p><p>Basic knowledge of HVAC system installation, operational techniques and safety compliance, instrumentation, and controls, and building automation systems.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div><div><p>The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
</p></div></div></div></div></div></div></div><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Technician, Industrial HVAC

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Technician, Facility Building Maintenance.
</p></div></div></div></div><div><div><div><div>Job Title: Technician, Facility Building Maintenance
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>This position ensures the proper maintenance and layout changes of all property, buildings, offices, labs, and manufacturing areas; takes corrective action and repairs walls, floors, ceilings, exterior buildings, parking lots and landscape as necessary; provides appropriate notification and documentation of all work performed. General maintenance and repairs within a GMP manufacturing facility.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><p>Responsible for building maintenance and repairs including, roof tops, exterior building repair and painting, flooring, carpeting, wall repair for GMP and non GMP areas, electrical covers, light bulbs, plumbing and overall internal and external building aesthetics.
</p><p>Responsible for completion of work orders, purchase requisitions and other documentation related maintenance and repairs.
</p><p>Responsible for maintenance of interior and exterior signage and security barrier.
</p><p>Responsible for alerting building internal/external issues to the immiediate attention of management.
</p><p>Responsible for grounds, removal of debris, leaves and fallen tree/palm branches including pressure cleaning of the lot and roof tops.
</p><p>Conference room set-ups for meetings and scheduled events. Assist with office moves (desks, boxes, furniture, file cabinets, cubicles, etc.)
</p><p>Responsible for contacting Waste Management for dumpster pick-up and ensuring lots are free of clutter.
</p><p>Assist in the maintenance of inventory to ensure adequate parts and supplies are on hand. Complete purchase requisitions for equipment and parts as needed. Receiving and stocking of parts and materials for Facilities and Maintenance.
</p><p>Create checklists and perform monthly walkthroughs and inspections to ADMA internal and external facilities including mechanical areas creating work orders for repairs and items needing of attention.
</p><p>Adhere to all ADMA SOPs, procedures, policies, and federal regulations in the operations of these facilities.
</p><p>Adhere to all ADMA Biologics, OSHA and other agencies State and Federal Safety policies and regulations.
</p><p>Assist in special projects and/or construction projects. Duties may include demolition, renovation, and new construction.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Ability to read and understand blueprints
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements
</b></h2></div><div><p>High School Diploma or equivalent
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div><div><p>The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.<br>
</p></div></div></div></div></div></div></div><p></p><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Technician, Facility Building Maintenance

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Technician I, Industrial Maintenance.
</p></div></div></div></div><div><div><div><div>Job Title: Technician I, Industrial Maintenance
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>This position ensures the proper operation and maintenance of all utility systems; takes corrective action and repairs equipment as necessary; provides appropriate notification and documentation of all work performed. General maintenance on mechanical, electrical, refrigeration and various maintenance and repairs within a GMP manufacturing facility.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><ul><li>Ensure utility areas are kept reasonably clean and free of debris or clutter.
</li><li>Perform routine Preventive Maintenance on boilers, stills, air compressors, pumps and other assigned equipment. Generate and maintain the required documentation.
</li><li>Perform and document daily rounds observing utility instruments, mechanical, electrical and other various aspects of the facility. Create additional work orders for any abnormal issues observed.
</li><li>Assist in plumbing, mechanical, and/or electrical equipment such as: pumps, circuit panels, refrigeration, WFI, boilers, HVAC chillers, air compressors, motors, etc.,
</li><li>Handle repairs and maintenance on equipment, as well as assigned work orders. Notification of appropriate personnel as needed. Create and maintain necessary documentation of these repairs.
</li><li>Adhere to all ADMA SOPs, procedures, policies and federal regulations in the operations of these facilities.
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Ability to read and understand blueprints
</div><div>Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures
</div><div>Able to work in high-pressure, deadline-driven environment
</div><div>Basic computer skills
</div><div>FDA Adherence
</div><div>Good mechanical aptitude and knowledge of general maintenance
</div><div>Good mechanical aptitude and knowledge of general maintenance.
</div><div>Individual must have the knowledge and experience to operate and maintain the facility and production systems, and associated equipment: high pressure steam, fuel oil, chilled water, low temperature coolant, nitrogen, compressed air, pretreatment water, water for injection, air handlers, condenser water, heating hot water, ethanol, emergency power, industrial waste, controlled environment areas
</div><div>Managing Time
</div><div>Must be able to read, understand, and implement programs based on technical regulations and manuals
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements
</b></h2></div><div><p>1-3 years previous general maintenance and/or construction experience needed, in the pharmaceutical/medical devices industry preferred. GMPs and ISO regulations knowledge needed for this position.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div><div><ul><li>The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
</li></ul></div></div></div></div></div></div></div><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Technician I, Industrial Maintenance

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an Senior Technician, Industrial Maintenance.
</p></div></div></div></div><div><div><div><div>Job Title: Senior Technician, Industrial Maintenance
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>This position has the responsibility to ensure the proper operation and maintenance of all facility systems and equipment. They will take corrective action and repair equipment when necessary. Provides appropriate notification and documentation of all work performed. Daily activities may include performing mechanical and/or electrical troubleshooting and tasks, PM activities, and other tasks involving various operations and repairs within a cGMP manufacturing facility. This position is known internally as Senior Facilities Operator.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><p>Responds to emergencies as requested utilizing resources to effectively repair and ensure the safety and availability of ADMA systems and equipment.
</p><p>On non-supervised shifts, the individual is responsible for the continued operations of the facility, plant, and production systems. This employee has the authorization in the absence of written procedures or instructions to start and stop equipment to ensure continued operation until necessary corrective action can be taken and if necessary, call in additional off-duty personnel to assist in problem resolution.
</p><p>Responsible for the proper operation and maintenance of all facility systems. This includes, but is not limited to the following: routine preventative maintenance; corrective maintenance and document related work performed, materials, parts and supplies used in work order documentation for systems like Water for Injection (WFI) systems, autoclaves, HVAC systems, steam systems, high capacity chillers, ultra-low temperature refrigeration systems, cooling towers, liquid pumping and compressible gas fluid systems including air compressors, nitrogen, natural gas, diesel fired boilers, clean steam, waste water systems etc.
</p><p>Performs the job function in compliance with safety, health, environmental, and governmental regulations and in compliance with ADMA SOPs for facility operations.
</p><p>Research codes and existing ADMA procedures for conformance to regulatory codes.
</p><p>Insure outside venders and contractors are trained in applicable ADMA procedures regarding safety, environmental, and health. They must also be monitored to comply with all ordinances such as electrical and construction codes.
</p><p>Assist the Instrumentation Technician II in the calibration and repair of devices within the manufacturing facility.
</p><p>Assist facility management in the training and the development of skills for Facility Operations I &amp; II.
</p><p>Ensure plant is clean and free of debris or clutter.
</p><p>Will assist in special projects and/or construction projects. Duties may include demolition, renovation, and new construction.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to read and understand blueprints
</div><div>Able to work in high-pressure, deadline-driven environment
</div><div>Good mechanical aptitude and knowledge of general maintenance.
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements
</b></h2></div><div><p><b>Education Requirements: </b>High school diploma or equivalent plus four (4) years of technical or vocational training. Equivalent experience may be substituted for technical/vocational experience.
</p><p><b>Experience Requirements: </b>Six years + previous maintenance in a manufacturing environment and/or construction experience. cGMPs and ISO regulatory knowledge needed for this position.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div><div><p><b>Preferred Education Requirements: </b>Florida Professional License preferred.
</p><p><b>Preferred Experience: </b>Six years&rsquo; experience in the pharmaceutical/medical devices industry preferred.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div><div><p>The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
</p></div></div></div></div></div></div></div><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Senior Technician, Industrial Maintenance

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a <b>Senior Process Engineer, Process Development located in Boca Raton, FL!
</b></p></div></div></div></div><div><div><div><div>Job Title: Senior Process Engineer, Process Development
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary<br>
</b></h2></div><p></p><div><p>The <b>Senior Process Engineer, Process Development </b>, will play a critical role in supporting the development and transfer of processes for IgG Immunotherapy Production. This position will regularly update the Process Development (PD) Management team to ensure compliance and operational efficiency. Responsibilities include maintaining compliance in the PD laboratory and executing process development, evaluation studies, and process validations using a scale-down model. As a key member of the PD team, this role will support Manufacturing, Quality Control/Assurance, and Regulatory departments.<br>
</p></div></div><p></p><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities<br>
</b></h2></div><p></p><div><ul><li>Provide technical support for issues related to the manufacturing process and product quality.
</li><li>Develop new processes as needed for the production of plasma-derived therapies.
</li><li>Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes.
</li><li>Optimize and maintain compliance in the PD laboratory by ensuring that all equipment calibration, IQ, OQ, and PM statuses are up to date.
</li><li>Participate in the design and planning of scientific experiments to meet corporate goals for existing projects.
</li><li>Review and/or approve cGMP documentation generated by other members of the PD group as needed.
</li><li>Lead the execution of process development and evaluation studies, as well as process validations using a qualified scale-down model.
</li><li>Oversee the transfer of process changes and/or new processes from PD to Manufacturing.
</li><li>Act as a liaison between PD and Manufacturing to support deviations, investigations, and process transfers.
</li><li>Maintain and review process development batch records for scale-down process models.
</li><li>Perform additional activities as assigned by PD Managers.
</li><li>Support Manufacturing, Engineering, and Quality Management in the development and implementation of new processes and technologies.
</li><li>Assist manufacturing personnel in executing process development and process validation studies within a cGMP production environment.
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Able to work in high-pressure, deadline-driven environment
</div><div>Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
</div><div>Possess time management skills and be able to balance multiple job assignments at once
</div><div>Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendations
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements<br>
</b></h2></div><p></p><div><p><b>Education Requirements:
</b></p>Bachelor&rsquo;s degree in Science, Engineering, or a related field is required.<br>
<ul><li>
</li></ul><p></p><p><b>Experience Requirements:
</b></p><ul><li>A minimum of 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment.
</li><li>Strong familiarity with various aspects of process development and a thorough understanding of FDA cGMP requirements is required.
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)<br>
</b></h2></div><p></p><div><p>The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
</p></div></div></div></div></div></div></div><div><div><div><div>Job Description Footer:
<p><b>In addition to competitive compensation, we offer a comprehensive benefits package including:
</b></p><ul><li>401K plan with employer match and immediate vesting
</li><li>Medical, Vision, Life and Dental Insurance
</li><li>Pet Insurance
</li><li>Company paid STD and LTD
</li><li>Company Paid Holidays
</li><li>3 Weeks&rsquo; Paid Time Off (within the first year)
</li><li>Tuition Assistance (after the first year)
</li><li>Easily accessible to Tri-Rail
</li>Free shuttle to the Boca Tri-Rail station<br>
<li>
</li></ul><p></p><p>ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .<br>
</p><p></p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Senior Process Engineer, Process Development

<div></div><div><div><div><div><div><div><p><b>ADMA Biologics </b>is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Manager, Data Integrity!
</p></div></div></div></div><div><div><div><div>Job Title: Senior Manager, Data Integrity
</div></div></div></div><div><div><div><div>Job Description:
<div><div><div><h2 class="jobSectionHeader"><b>Position Summary
</b></h2></div><div><p>The Senior Manager, Data Integrity will lead the development and implementation of IT-driven data governance strategies, ensuring the integrity and regulatory compliance of all digital data across the organization&rsquo;s systems. This role will be responsible for implementing and maintaining cGMP applications throughout its SDLC. This role is critical in maintaining the accuracy, security, and quality of data within a highly regulated environment.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Functions (ES) and Responsibilities
</b></h2></div><div><p>Lead the creation and execution of data governance policies, focusing on IT systems to ensure the integrity, accuracy, and security of data across manufacturing, laboratory, and quality systems.
</p><p>Oversee data management practices within IT to guarantee full compliance with FDA, SOX, and other relevant regulatory bodies, ensuring that all digital and automated data meets industry standards for integrity and reliability.
</p><p>Regularly perform comprehensive audits of IT systems, including databases, software applications, and digital workflows, to identify and address any data integrity risks or discrepancies.
</p><p>Responsible for the entire lifecycle of cGMP applications including the implementation and maintenance of applications.
</p><p><b>Lead System Administrators </b>to maintain laboratory systems including, but not limited to, LabVantage LIMS (all modules), Empower 3, and SoftMax 7
</p><p>Develop and deliver specialized training programs for IT and cross-functional teams, ensuring they understand and adhere to data integrity best practices within the context of IT systems and regulatory compliance.
</p><p>Partner with IT, Quality Assurance, Manufacturing, Regulatory Affairs, and other departments to ensure data integrity is maintained across all stages of the product lifecycle, leveraging IT systems and technology.
</p><p>Lead continuous improvement initiatives within IT, focusing on enhancing data quality and integrity through the adoption of new technologies, tools, and best practices.
</p><p>Identify, assess, and mitigate risks to data integrity within IT systems, developing proactive strategies to safeguard compliance and product quality across digital platforms.
</p><p>Guide the selection, validation, and deployment of IT systems, ensuring they meet stringent data integrity standards and align with the organization's operational goals and regulatory requirements.
</p><p>Maintain and oversee the accuracy, accessibility, and regulatory compliance of all IT-related data documentation, including system validation records, data archiving, and retrieval processes.
</p><p>Regularly update senior management on the status of data integrity initiatives, providing insights and recommendations to enhance IT governance and reduce compliance risks.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Job Responsibilities or Job Requirements
</b></h2></div></div><div></div><div><div><h2 class="jobSectionHeader"><b>Competencies
</b></h2></div><div><div>Ability to effectively manage staff. Ability to handle multiple priorities and tight deadlines. Understand concepts, requirements, and accounting issues for all business areas
</div><div>Ability to follow the cGMP&rsquo;s and procedures with great attention to detail
</div><div>Ability to understand and interpret government regulations and customer specifications
</div><div>Able to work in high-pressure, deadline-driven environment
</div><div>Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management
</div></div></div><div><div><h2 class="jobSectionHeader"><b>Experience Requirements<br>
</b></h2></div><div></div><div><p>8-10 years of experience in data integrity, information management, or related IT roles within highly regulated industries such as biopharmaceuticals, biotechnology, or healthcare.
</p><p>At least 3-5 years of leadership experience in IT management, with a demonstrated ability to lead cross-functional teams in the implementation and oversight of laboratory and manufacturing data integrity programs.
</p><p><b>Education Requirements: </b>Bachelor&rsquo;s degree in information technology, Computer Science, Data Management, or a related technical field.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Experience
</b></h2></div><div><p>Proven experience with regulatory compliance frameworks and standards (e.g., FDA, SOX, 21 CFR Part 11) as they apply to data management and IT systems.
</p><p>Proven experience supporting laboratory systems such as LabVantage LIMS, Empower 3, SoftMax 7 is strongly preferred
</p><p>Experience with MES and SAP systems is a plus
</p><p>Extensive experience with IT systems and data management technologies, including validation, security, and governance of enterprise-level data systems.
</p><p>Strong understanding of industry best practices for data integrity and information security, particularly within GxP environments.
</p><p>Familiarity with cloud-based solutions and the challenges associated with maintaining data integrity in cloud environments, including knowledge of related security protocols and regulations.
</p><p>Strong project management skills with a track record of successfully leading large-scale IT projects related to data governance and system validation, including experience with methodologies like Agile or Six Sigma.
</p><p>Advanced certifications in data governance, information security, or regulatory compliance, such as Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), or Certified Data Management Professional (CDMP).
</p><p><b>Preferred Education Requirements: </b>A Master&rsquo;s degree in Data Science, Information Systems, or a related discipline, particularly with a focus on data governance, cybersecurity, or regulatory compliance.
</p></div></div><div><div><h2 class="jobSectionHeader"><b>Compliance Requirements (ES)
</b></h2></div><div><p>The minimum compliance expectation for this role entails strict adherence to FDA (Food and Drug Administration) regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
</p></div></div></div></div></div></div></div><div><div><div><div>Job Description Footer:
<p>In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks&rsquo; Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .
</p><p>ADMA Biologics is an Equal Opportunity Employer.
</p></div></div></div></div><div><div>Apply now</div></div></div></div>

Senior Manager, Data Integrity

Join ADMA Biologics and explore 33   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.