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 and cell and gene therapies. 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 QA Scientist will provide technical and scientific expertise in support of activities associated with  the re-establishment and startup of a commercial GMP Biologics Facility. Duties for this role include support of operational readiness activities, review of process and facility validation strategy, investigation and closure of quality events including Deviation, CAPA, and Change Control as well at master batch record approval. The QA Scientist also supports routine manufacturing operations, customer project teams, and efforts in continuous improvement at AGC Biologics.

 

PRINCIPAL RESPONSIBILITIES:

  • Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
  • Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems.
  • Interprets regulations and guidelines critical for advancement of QA systems.
  • Independently leads compliance assessments and oversight associated with validation and facility startup of facility and review of associated documentation required to startup and maintain the facility and production.
  • Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives.
  • Accountable for decisions and results that ensure timelines are met.
  • May lead projects or represent QA interests in multidisciplinary project teams.
  • Works closely with other team members in a cooperative fashion to ensure project progression and timeline adherence.
  • May support and contribute to the direction and decisions of AGC Biologics project teams.
  • Responsible for making recommendations in accordance with regulatory expectations and industry standards.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Must possess strong technical and analytical understanding of Biologics Manufacturing and testing.
  • Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
  • Knowledge of scientific principles and concepts as they relate to GMP Operations.
  • Knowledge of CAPA, change control and deviation programs and requirements.
  • Great team player who is collaborative and positive.
  • Ability to understand and apply GMP regulations as they relate to manufacturing, analytical testing and facility operations.
  • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
  • strong interpersonal, written/oral communication and problem solving skills.

 

EDUCATION/EXPERIENCE:

  • BA or BS with at least 10 years QA-related experience or equivalent work experience or a PhD in a scientific discipline with at least 2 years related experience; may include post-doctoral experience or equivalent work experience.
  • Experience with application of compliance principles which drive QA strategy.
  • Experience in change control facilitation and closure.
  • Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
  • Equivalent education and experience may substitute for stated requirements.

 

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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