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:

AGC Biologics is looking for a Quality Systems Associate III with a focus on GMP auditing and compliance.  The primary responsibilities for this role include executing the internal audit program supporting a commercial drug substance manufacturing plant.  Additionally, this position has responsibility for compliance assessment for deviation, CAPA, and change control.  This role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.  Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

 

PRINCIPAL RESPONSIBILIITES:

  • Creates and drives the execution of the internal audit schedule.
  • Audits SOP(s) to ensure contents meet regulatory requirements and interpretations.
  • Audits records and reports to ensure they accurately reflect the protocols, SOP(s), production records, procedures and actual data results obtained during GMP operations.
  • Identifies noncompliance and deviations, and recommends corrective and preventative actions in an educational and persuasive manner.
  • Issues audit reports to disclose noncompliant findings to Management and verify their follow-up responses are adequate and complete to close the audit.
  • Provides support with client and regulatory audits or any department goals as requested by supervisor or manager.
  • Identifies opportunities for improvement to optimize the Internal Audit program.
  • Identifies and communicates opportunities for improvement in the audited areas, providing suggestions to apply best practices.
  • May participate on client project teams.
  • Actively participates in cross-functional compliance improvement projects.
  • Provides support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
  • Independently determines and develops approach to solutions.
  • Other duties as assigned.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong understanding of cGMP’s and concepts in several quality systems. 
  • Demonstrated deep understanding of procedures and methods for review function.
  • Ability to make independent decisions.
  • Demonstrated understanding of procedures and methods for review function.
  • Demonstrated depth understanding of how systems interrelate.
  • Demonstrated ability to multi-task and work on several QA projects and problems.
  • Ability to deduce next steps on problems with minimal direct supervision.
  • Ability to work under only general direction.
  • Understanding of basic scientific/technical concepts.
  • Good analytical skills. 
  • Clear, concise writing skills.
  • Good verbal presentation skills. 
  • Excellent organizational skills and attention to detail. 
  • Ability to interact constructively with co-workers.

 

EDUCATION/EXPERIENCE:

  • BS in Chemistry, Biology or other relevant discipline or equivalent work experience.
  • 5+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP). 

 

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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