Quality Assurance Associate III
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 Associate II/III (In-Plant Operations) is responsible of overseeing and providing in-plant support to the following activities at the site.
PRINCIPAL RESPONSIBILITIES:
- Review of executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
- Review and approval of Master Production Records (MPRs) and other procedures.
- Approve equipment cleaning and change over operations.
- Approve calibration and maintenance records for GMP operations.
- Collaborate in the resolution of issues associated with manufacturing operations as the QA point-of-contact, providing guidance in deviation initiation and facilitate the resumption of manufacturing activities post deviation detection.
- Triage deviations during and post manufacturing, support implementation of corrective and preventive actions and participate in investigation teams.
- Participate and lead improvement initiatives aimed to add efficiency to Quality processes.
- Provide support during internal/client audits and regulatory inspections.
- This position is Tuesday to Friday 10am to 8pm and will support Manufacturing, Quality Control, and Engineering activities.
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.
- 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.
- Understanding of basic scientific/technical concepts.
EDUCATION/EXPERIENCE:
- Bachelor's degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience.
- Minimum 2 - 5+ years' of QA-related experience, including interpretation and application of regulatory principles which drive QA strategy.
- 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.