AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .

 Summary: 

The Quality Assurance Associate III is responsible for administration of Quality Operations Activities associated with material management and release, lot disposition, and in-plant QA in compliance with applicable regulatory guidelines and requirements.

PRINCIPAL RESPONSIBILITIES:

  • Review and approve controlled documents including analytical assays, Standard Operating Procedures, Manufacturing Batch Records, and Validation protocols and reports.
  • Review material release documentation and disposition materials for use in cGMP manufacture.
  • Review QA data generated from manufactured product and intermediates and stability testing and approve results summaries.
  • Review and approve simple Change Requests, simple deviations and corresponding CAPA.
  • Support in-plant operations by conducting in-plant review of batch records and providing QA support for operations.
  • Review executed manufacturing batch records for completeness, compliance, and accuracy and partner with others for corrections as necessary.
  • Create and review documents to be included in DHRs.
  • Review and approve equipment onboarding and preventative maintenance and repair work orders.
  • Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes

KNOWLEDGE, SKILLS & ABILITIES:

  • Technical and analytical understanding of Biologics Manufacturing and testing.
  • Knowledge of regulatory compliance principles, strategy and rational as they relate to Biologics Manufacturing.
  • Good oral and written communication skills.
  • Good organizational skills.
  • Demonstrated experience in areas of teamwork and problem-solving.
  • Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors.
  • Understanding of basic scientific/technical concepts.

EDUCATION/EXPERIENCE:

  • BS degree in Biology, Chemistry or other relevant discipline preferred.
  • Minimum 5+ year of QA-related or 2 years of pharmaceutical/device manufacturing or Quality Control experience. Advanced degrees in Biology, Chemistry, or related discipline may substitute for work experience.

 COMPENSATION:

$71,000 – $89,300

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

 

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