myGwork - LGBTQ+ Business Community · 1 week ago

Engineer III, QA

Missouri, United States

Full-time

Onsite

Senior Level

5+ years exp

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Responsibilities

Oversees and ensures the successful day-to-day oversite of contract manufactured biologic molecule(s).

Provide a positive working relationship and constructive support for clients.

Responsible for providing oversite and updates for quality related items for the project. guidance on regulations, especially Q7A and 21CFR Parts 210 and 211, alignment to Quality Agreements, and product disposition.

Act as Liaison between the Client and sub-groups of Quality Assurance during technology transfer of new products; ensuring development of process adheres to applicable regulations based on phase appropriate FDA, EMA, and ICH guidelines. Guidance to include work from Process Development to Process Validation.

Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and resolve next steps.

Monitor quality related issues (deviations, CAPAs, change controls) coordinates resolution, and communicates with peers, colleagues, and clients regarding status of resolution to mitigate delays in product releases.

May provide guidance or direction to other personnel relative to assistance with prioritization and investigations to meet product release target

Review and approval of GMP document as required for such documents as but not limited to, Standard Operation Procedures, Technical Transfer Protocols, Deviations, CAPAs, and Change Controls.

Actively participate in client project team and QA meetings with clients as needed to monitor and address any quality items impacting clients or product releases.

Contribute to continuous process improvement projects drive improvements in the product release process and providing superior customer service.

Support client audits as needed, as a participant or the development of audit responses.

Qualification

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Quality/manufacturing/process engineeringCGMP regulationsFDA/EMA regulatory requirementsGMP regulationsBiopharmaceutical manufacturingQuality controlProblem solvingCritical thinkingInterpersonal skillsProject managementContinuous improvement mentalityQuality Management

Required

Bachelor's Degree in Life Sciences (chemistry, biology, biochemistry), Chemical / Biochemical engineering, or other scientific field.

5+ years proven experience in Quality / Manufacturing / Process Engineering in a regulated environment

In depth knowledge of cGMP regulations

Solid understanding of FDA/EMA regulatory requirements applicable to pharmaceutical or biologics Quality Systems.

Ability to apply GMP regulations and other international guidelines to all aspects of the position.

Technical knowledge of biopharmaceutical manufacturing and/or quality control is desirable.

Strong interpersonal skills to be used with varying organizational levels and a proven record to make key decisions.

Strong attention to detail, problem solving, and critical thinking skills

Critical thinking with the ability to prioritize multiple priorities simultaneously.

Strong project management skills

Continuous improvement mentality

Able to work collaboratively with various departments in the organization and clients to identify and implement solutions to address quality/compliance issues.