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.
The Supervisor, QA (In Plant Operations) is responsible of leadership and quality oversight to the following activities at the site.
- Review of manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
- Review of QC testing data generated from manufactured product and intermediates and approve results summaries.
- Triage deviations during and post manufacturing and support implementation of corrective and preventive actions and participate in investigations teams.
- Approve equipment cleaning and change over operations.
- Support review and approval activities of Master Batch Records (MBRs).
- Approve of calibration and maintenance records, raw materials testing and other documentation supporting GMP operations.
- Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.
- Provide Subject Matter Expert (SME) support during internal/clients audits and regulatory inspections.
- Collaborate in the resolution of issues associated with the manufacturing operations, becoming the QA point-of-contact, providing guidance and facilitate the resume of manufacturing activities post deviation detection.
- Provides direct supervision to exempt employees and/or skilled no exempt employees.
- Assigns daily/weekly tasks to staff members.
- Performance appraisals.
- Participate in and facilitates teams supporting regulatory inspections.
- Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Strong technical and analytical understanding of Biologics Manufacturing and testing.
- Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
- Good organizational skills.
- Demonstrated leadership in areas of teamwork and problem-solving.
- Expert knowledge of regulatory and compliance principles and concepts as they relate to Operations Ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Demonstrated ability to interact with cross-functional teams in order to ensure the compliance of the GMP operations at the site.
- Demonstrated strong understanding of procedures and methods for review function.
- BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
- 5+ years’ QA-related experience in a pharmaceutical or FDA/GMP environment.
- Supervisory experience and demonstrated ability to manage staff and multiple tasks to deliver on time results.
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.