Qureos Mentor

UNION AGENER

<div><div><b>Position Description, Functions, Duties and Tasks:</b><br>
<b>Position Description: </b>The Technician serves as a resource for the method execution to support the<br>
release of Raw Materials, In Process samples, Active Pharmaceutical Ingredients, and Finished<br>
Products. The Technician will own the testing and associated data related to Certificate of Testing.<br>
The Technician will be knowledgeable of laboratory operations and execute methods per standard<br>
operations procedures and escalate any issues to the Chemist.</div>
<div><br>
<b>Functions, Duties, Tasks:</b></div>
<ul><li>Assists Chemists in the update of quality systems for analytical testing.</li>
<li>Provides technical support for continuous improvement in operations by involvement in SOPs and change control systems.</li>
<li>Assists in the continued training and development of all team members in the areas of safety, cGMP compliance, and on-the-job requirements.</li>
<li>Reviews and approves SOPs and analytical data.</li>
<li>Assesses any out-of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective action, as needed.</li>
<li>Prepares systems trends utilizing statistical process control.</li>
<li>Participates in quality audits as needed.</li>
<li>Performs the following procedures: HPLC, SDS Page, UV, Dissolution Testing, Viscometry,</li>
<li>Particle Size, KF, AA, and etc., as needed.</li>
<li>Perform Wet Chemistry testing.</li>
<li>Effectively interfaces and communicates with manufacturing personnel to ensure that the analytical needs of the manufacturing facility and operations are met.</li>
<li>Follows appropriate protocols, SOPs, compendial and analytical methods, and stability protocols for sampling and testing raw materials, bulk powder and finished product.</li>
<li>Performs basic diagnostic and troubleshooting procedures for laboratory equipment, as needed.</li>
<li>Performs basic diagnostic and troubleshooting procedures for test methods.</li>
<li>Prepares controls, standards, solutions, samples, and maintains proper documentation as required by the QC laboratory.</li>
<li>Assist with receiving samples into QC.</li>
<li>Prepare samples for testing and shipping to external laboratory.</li>
<li>May write and revise supporting SOP&rsquo;s and specifications.</li>
<li>Maintains appropriate equipment, records, files, and logs according to SOPs and appropriate regulatory requirements.</li>
<li>Assists in the maintenance of laboratory requirements, including reagents and supplies.</li>
<li>Performs all activities in a safe and conscientious manner. Maintains a clean environment and assists with periodic lab clean-ups, and moving of equipment and laboratory supplies.</li>
<li>Data entry into applicable database</li>
<li>Able to handle change productively and handle other tasks as assigned.</li>
</ul><div><b>Minimum Qualification (Education, Experience and/or Training, Required Certifications):</b></div>
<ul><li>At a minimum an Associate&rsquo;s degree in science is required or a minimum of 5 years of lab experience</li>
<li>Familiarity with compendial testing (i.e., USP/NF) strongly desired</li>
<li>Computer skills (Excel, Word, Empower, SAP)</li>
</ul><div><b>Additional Preferences:</b></div>
<ul><li>B.S. Degree in Chemistry or other scientific-related field strongly preferred</li>
<li>Preference will be given to candidates with a minimum of two (2) to three (3) years of experience in a QC laboratory, preferably in a manufacturing facility.</li>
<li>Basic understanding of cGMP for QC laboratories preferred</li>
<li>Must possess excellent communication and organization skills</li>
<li>Strong interpersonal and team building skills required; must show desire and ability to work in a team environment</li>
<li>Must be able to function independently and responsibly with little supervision</li>
<li>Must be detail-oriented and able to accurately follow protocols and SOPs.</li>
<li>Flexibility and ability to changing priorities and unforeseen events; excellent time management skills.</li>
</ul><div><div><b>What do we offer?</b></div>
<ul><li>Competitive Salary</li>
<li>Competitive Benefits Package and Employee Assistance Program</li>
<li>401(k) Plan + Company Match</li>
<li>Vacation + End of Year Vacation (Company Sponsored)</li>
<li>Growth Opportunities to expand your career</li></ul></div></div>

QC Chemistry Technician

<div><div><div><div><div><div><b>Position Description, Functions, Duties and Tasks:</b></div>
<div>Supplier qualification for Packaging Materials</div>
<ul><li>Prospect and define new suppliers</li>
<li>Organize, schedule, participate and document (on the specific form) the packaging material tests</li>
<li>Assist with new projects and improvements related to packaging and packaging materials</li>
</ul><div>Development and maintenance of artworks and specifications:</div>
<ul><li>Start and manage the flow of the creation/review/approval/release of artwork and specification;</li>
<li>Request new codes of packaging material and perform the follow-up of the creation of the codes;</li>
<li>Open change management related to change of artwork and specification;</li>
<li>Project manage the implementation and timing of the PMD changes</li>
<li>Represent Packaging Material Development (PMD) on Change Management (CM) meetings.</li>
</ul><div>Process and packaging improvements:</div>
<ul><li>Assist in project improvement initiatives that may include Packaging, Operations and QC Incoming.</li>
</ul><div>Documentation:</div>
<ul><li>Perform the draft, review and approval step of technical documents as SOPs, technical drawings, artworks, specifications, analytical methods and registers.</li>
<li>Perform the follow-up of the PMD documents.</li>
<li>Send the artwork/PMS/TD to the packaging material suppliers as part of the quoting process.</li>
<li>Assist in technical evaluations of packaging material deviations.</li>
<li>Approve electronic print proofs.</li>
</ul><div>Syringe Components:</div>
<ul><li>Assist the PMD Manager as needed with syringe component support. This may include:
<ul><li>Aid in optimizations of testing and material flow to increase efficiencies, safety/ergonomics while maintaining Quality.</li>
<li>Actively participate in safety-related activities (audits, hazard reviews, etc.) to drive ongoing safety improvement.</li>
</ul></li><li>Interact with Regulatory Agencies during audits and assessments.</li>
<li>Assist in troubleshooting efforts to resolve more difficult process and operational challenges.</li>
<li>Utilize formal problem solving techniques, including Root Cause Analysis, to resolve process deviations.</li>
<li>Assist with implementation of corrective actions arising from deviation CAPAs.</li>
<li>Participate in Annual Product Reviews for systems.</li>
<li>Assist the PMD team to drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with processes within the area.</li><br>
</ul></div></div><br>
<div></div><div><div><div><b>Minimum Qualification (Education, Experience and/or Training, Required Certifications):</b></div>
<h1 class="jobSectionHeader"><b>Education:</b></h1>
<ul><li>A BS degree in Chemistry, Engineering or related field.</li>
</ul><div>Experience:</div>
<ul><li>2+ years experience in FDA regulated manufacturing operations.</li>
<li>Understanding and experience with pharmaceutical cGMPs, preferably those related to prefilled sterile syringe manufacturing and packaging requirements.</li>
</ul><div>Required Skills:</div>
<ul><li>Understand and apply pharmaceutical cGMPs to all aspects of work processes.</li>
<li>Strong written and oral communication skills. Communicate effectively with all levels of the organization, from plant management to operations personnel.</li>
<li>Excellent organizational, project, and time management skills. Able to handle change productively and other tasks as assigned.</li>
<li>Strong interpersonal and communications skills to be able to work effectively in a team-based environment and to interact with global regulatory agencies.</li>
<li>Strong technical knowledge and problem solving skills.</li>
<li>Demonstrated ability to manage multiple priorities independently.</li>
<li>Strong computer skills in a variety of software packages (Excel, JMP, Visio etc.).</li>
<li>Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.</li>
<li>Ability to apply statistical thinking concepts to the analysis of manufacturing problems.</li><br>
</ul></div></div><br>
<div></div><div><div><div><b>Additional Preferences:
</b></div><ul><li>Experience with CFR 820, ISO 13485</li>
<li>Project management skills</li>
<li>Gamma and Ethylene Oxide Sterilization experience</li>
<li>Plastic mold injection experience</li>
<li>Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach</li>
<li>Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes</li>
<li>Ability to develop effective working relationships with team members and management with</li>
</ul><div>diverse interpersonal styles.</div>
<ul><li>Experience with Adobe Illustrator</li><br>
</ul></div></div><br>
<div></div><div><div><div><b>Other Information:
</b></div><ul><li>Must be able to travel to all areas of the plant which may include walking, climbing various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building.</li>
<li>Occasional travel: &lt;20%</li></ul></div></div></div></div></div>

Packaging Material Development Associate

Join UNION AGENER and explore 2   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.

UNION AGENER

ABOUT_COMPANY

QC Chemistry Technician

Packaging Material Development Associate