Qureos Mentor

PCI Pharma Services

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Summary of Objective:</div><div></div><div>
The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Laboratory including completing the majority of the peer review in the department and approving the majority of procedures used in the analytical department. The work includes the testing of in-process samples, finished product samples and raw materials. The QC Analytical Supervisor will communicate with clients regarding Out of Specification and other Quality System Events. The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of his/her responsibilities. Also, must be familiar with cGMPs as they relate to analytical test methodologies and practices.</div><div>
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.</div><ul><li><div>
Prioritize and distribute work to the analysts working in the QC Analytical laboratory</div></li><li><div>
Conduct OOS and customer complaint investigations</div></li><li><div>
Complete peer review of work executed within the analytical laboratory</div></li><li><div>
Train new Employees</div></li><li><div>
Routine Analytical testing of samples supporting incoming raw materials, in-process production and finished product testing</div></li><li><div>
Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required</div></li><li><div>
Perform instrument calibrations and preventative maintenance as needed Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements</div></li><li><div>
Write, review and revise SOPs as required</div></li><li><div>
Other duties as assigned or required</div></li></ul><div></div><div>
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.</div><ul><li><div>
Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.</div></li><li><div>
Capacity to work on several tasks simultaneously.</div></li><li><div>
Able to organize and prioritize work activities.</div></li><li><div>
Must be able to walk and drive between locations</div></li><li><div>
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves</div></li><li><div>
Comfortable with working/handling of hazardous materials</div></li></ul><div></div><div><br>
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div><ul><li><div>
Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities.</div></li><div></div><li><div>
Interacts with Operations staff, Research and Development staff and clients on a regular basis.</div></li><li><div>
Supervises the employees in the QC Analytical departmen</div></li><li><div>
TRAVEL &ndash; &lt;10%</div></li></ul><div></div><div><br>
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div><ul><li><div>
5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company</div></li><li><div>
Experience working in a cGMP laboratory required</div></li><li><div>
Experience working in a CMO (contact manufacturing/development organization) preferred</div></li><li><div>
Prior leadership experience is preferred</div></li><li><div>
Bachelor of Science in a scientific area of study</div></li><li><div>
Master of Science in a scientific area of study and 3+ years Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company</div></li><li><div>
Ability to prioritize tasks for staff</div></li><li><div>
Ability to make informed decisions</div></li><li><div>
Detail oriented</div></li><li><div>
Strong oral and written communication skills</div></li><li><div>
Excellent organization skills</div></li><li><div>
Office Suite experience (Excel, Word, Access, and PowerPoint)Bachelor of Science in a scientific area of study</div></li></ul><ul><li><div>
Excellent interpersonal skills and the ability to communicate well both orally and in in writing</div></li><li><div>
Ability to multi-task in a dynamic environment with changing priorities</div></li><li><div>
Resilient, can quickly move forward despite challenges</div></li><li><div>
A drive to achieve results for self, and the team, and is cable of working with limited supervision</div></li><li><div>
Positive attitude and strong team, cross team collaboration</div></li><li><div>
Honesty, integrity, respect and courtesy with leadership and peers</div></li><li><div>
Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services</div></li><li><div>
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#LI-LL1</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Supervisor, QC Analytical Wed to Sat 6:30 AM to 5PM

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
JOB DESCRIPTION:</div><div></div><div>
Position Title: Supervisor, QA Internal Operations</div><div>
Location: Bedford, NH</div><div>
Department: Quality Assurance Internal Operations</div><div>
Reporting To: Senior Manager QA Operations</div><div>
Responsible For (Staff): Yes</div><div></div><div>
The Supervisor, QA Internal Operations is responsible for leading a team of QA Operations Associates responsible for on-the- floor support (Quality in Plant &ndash;or QIP) that provides 7 days a week QA oversight. This includes providing QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. The QA Supervisor assists in assisting with quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Visual Inspection, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.</div><div></div><div>
ESSENTIAL DUTIES AND RESPONSIBILITIES:</div><div></div><ul><li>
Oversee and provide QA support and guidance for daily cGMP manufacturing operations.</li><li>
Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release.</li><li>
Support scheduling activities by monitoring the production and visual inspection schedules and reviewing factors that may impact schedules.</li><li>
Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances; Assist with AQL Sampling and Inspection of Final Package Lots.</li><li>
Review and approval of Blue Mountain documents and work orders</li><li>
Complete staff performance reviews and align personnel goals to corporate initiatives.</li><li>
Ensure all pertinent training is assigned to staff, and employee training is in good standing</li><li>
Assist with review of master and executed raw material records and logbooks</li><li>
Review of associated QC data to support facility and products</li><li>
Participation in writing or revising Standard Operating Procedures, material control procedures, deviations, CAPA&rsquo;s, and Quality Investigations when applicable.</li><li>
Support external client audits at LSNE, and regulatory inspections</li><li>
Obtain gown qualification for sterile manufacturing line clears</li><li>
Maintain and evaluate current processes and procedures, and look for opportunities for continuous improvement</li><li>
Other duties as assigned</li><li>
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices</li></ul><div>
Assist QA Specialists in batch record reviews and generating CoAs</div><div></div><div>
QUALIFICATIONS:</div><div></div><div>
Required:</div><ul><li>
Bachelor&rsquo;s Degree in relevant scientific discipline</li><li>
5+ years of pharmaceutical or biotech industry experience</li><li>
3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production, or equivalent.</li><li>
ASQ certification Highly preferred</li><li>
Exceptional organizational skills and attention to detail</li><li>
Ability to make risk based decisions and resolve issues with minimal guidance</li><li>
Excellent interpersonal skills and the ability to communicate well orally and in writing</li><li>
Proficiency in MS Office including Word, and Excel</li><li>
Excellent verbal and written communication skills required</li></ul><div></div><div>
Preferred:</div><ul><li>
Ability to supervise and lead people in a dynamic, fast paced work environment</li><li>
Honesty, integrity, respect and courtesy with all colleagues</li><li>
Creative with the ability to work with minimal supervision and balanced with independent thinking</li><li>
Resilient through operational and organizational change</li><li>
Ability to coach, train, and mentor others</li><li>
Cross functional staff, members of management, internal and external clients, members of the Quality organization</li></ul><div></div><div>
#LI-RS1</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Supervisor, QA Internal Operations

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Summary of Objective:</div><div>
This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&amp;D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management</div><div></div><div>
Essential Duties and Responsibilities:</div><ul><li><div>
Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples.</div></li><li><div>
Assist in deviation investigation, out-of-specification or aberrant results and process changes</div></li><li><div>
Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data</div></li><li><div>
Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support</div></li><li><div>
Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed</div></li><li><div>
Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in compliance with cGMP/GDP requirements</div></li><li><div>
May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation</div></li><li><div>
Performs routine data generation and problem solving</div></li><li><div>
Other duties, as assigned</div></li></ul><div></div><div>
Special Demands:</div><ul><li><div>
Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear</div></li><li><div>
Ability to sit or stand for prolong periods of time</div></li><li><div>
Must be able to walk and drive between locations</div></li><li><div>
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves</div></li><li><div>
Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly</div></li><li><div>
Must be able to occasionally lift and/or move up to 50 pounds</div></li><li><div>
Comfortable with working/handling of hazardous materials</div></li></ul><div></div><div>
Work Environment:</div><div>
Works closely with quality assurance and quality control staff in performing varied work procedures and activities. Interacts with Operations staff.</div><div></div><div>
Qualifications:</div><ul><li><div>
0-3 years relevant Analytical Chemistry experience, preferably in Quality Control</div></li><li><div>
Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study</div></li><li><div>
General knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer and Osmometer is preferred</div></li><li><div>
Excellent organizational skills and ability to document technical data</div></li><li><div>
Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization</div></li><li><div>
Ability to multi-task in a dynamic environment with changing priorities</div></li><li><div>
Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.</div></li></ul><div>
#LI-LL1</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

QC Chemist I

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Summary of Objective:</div><div>
The senior manager is accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site. The senior manager provides leadership to ensure the highest level of quality and adherence to cGMPs across the site. This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department. Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations. Additionally, responsible for management of site CAPEX projects and acts as site representative for PCI&rsquo;s Environmental, Social, and Governance program.</div><div></div><div>
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.</div><div></div><ul><li><div>
Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI&rsquo;s established SOPs. Makes the necessary recommendations and changes to improve process efficiencies.</div></li><li><div>
Ensures all projects are executed safely, on time, and within budget.</div></li><li><div>
Identifies, prepares and leads site CAPEX projects.</div></li><li><div>
Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs.</div></li><li><div>
Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects.</div></li><li><div>
Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index.</div></li><li><div>
Oversees the departmental budget and headcount</div></li><li><div>
Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.</div></li><li><div>
Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations</div></li><li><div>
Directs general and specialized maintenance, CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities within the Madison, WI site.</div></li><li><div>
Support a variety of regulatory and client audits.</div></li><li><div>
Ensures team compliance with all corporate policies and procedures.</div></li><li><div>
Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to engineering, maintenance, and facilities areas.</div></li><li><div>
Works closely with key functions such as Quality, Manufacturing, EH&amp;S, Sales/Project Management, Global Engineering, and Global PMO to ensure internal and external clients&rsquo; requirements are met.</div></li><li><div>
Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed and streamline processes.</div></li><li><div>
Responsible for on time calibration and preventive maintenance schedules for 1300+ site assets including fill line equipment, clean utilities, and laboratory equipment.</div></li><li><div>
Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers.</div></li><li><div>
Supports Continuous improvement activities tied to budget goals and helps lead key ESG initiatives.</div></li><li><div>
Directs assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate.</div></li><li><div>
Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities.</div></li><li><div>
Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external).</div></li><li><div>
Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities.</div></li><li><div>
Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning.</div></li><li><div>
Part of the Site Leadership Team (SLT).</div></li><li><div>
Performs other duties as assigned.</div></li></ul><div></div><div>
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div><div></div><ul><li><div>
Bachelor&rsquo;s degree in engineering discipline preferred.</div></li><li><div>
Master&rsquo;s degree in engineering or business administration preferred.</div></li><li><div>
Operational background in cGMP environment, preferably in aseptic manufacturing/engineering.</div></li><li><div>
Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources.</div></li><li><div>
Experience in working with regulators during inspections/audits is highly desired.</div></li><li><div>
8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities.</div></li><li><div>
8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation.</div></li><li><div>
5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities.</div></li><li><div>
5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation.</div></li><li><div>
Experience with company financial systems and an understanding of accounting practices and financials a plus.</div></li><li><div>
Experience with direct exposure to Customers in a CDMO business is a plus.</div></li><li><div>
Demonstrate commitment to continuous improvement at all levels within the organization.</div></li><li><div>
Excellent organizational skills</div></li><li><div>
Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines</div></li><li><div>
Excellent verbal and written communication skills</div></li><li><div>
Ability to effectively manage multiple projects, teams and technical staff at all levels</div></li><li><div>
Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development. Setting future leadership for success.</div></li><li><div>
Performance measurement and KPI Tracking and Reporting</div></li><li><div>
Proficiency with MS Office suite is preferable.</div></li><li><div>
Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment.</div></li><li><div>
Leads by example to motivate and engage through clear communication, of vision and goals.</div></li><li><div>
Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully.</div></li><li><div>
Effective verbal and written communication with both internal and external contacts is critical to success</div></li><li><div>
Oversees a wide array of subordinate managers, supervisors, and technicians across multiple shifts.</div></li><li><div>
Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach.</div></li><li><div>
&lt;10% domestic and some international</div></li></ul><div></div><div><br>
Join us and be part of building the bridge between life changing therapies and patients. Let&rsquo;s talk future.</div><div></div><div>
Equal Employment Opportunity (EEO) Statement:</div><div>
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Sr. Manager, Engineering, Maintenance & Facilities

Join PCI Pharma Services and explore 4   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.

PCI Pharma Services

ABOUT_COMPANY

Supervisor, QC Analytical Wed to Sat 6:30 AM to 5PM

Supervisor, QA Internal Operations

QC Chemist I

Sr. Manager, Engineering, Maintenance & Facilities