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 QA Associate III (Regulatory Compliance Specialist) is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements. This role requires attention to detail, organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent.
PRINCIPAL RESPONSIBILITIES:
- Support with Regulatory Inspection Readiness
- Inspection Preparedness
- Maintain inspection readiness through inspection preparedness program and periodic readiness verification
- Execute against plan (training, document readiness, response preparation and readiness)
- Maintaining the Quality Systems in compliance with cGMP, FDA and ICH applicable regulations.
- Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
- Create and update SOPs, company Policies and other GMP documents.
- Support the internal audit program
- Maintain the internal audit schedule
- Coordinate with internal auditors
- Support the program to pro-active management of clients to ensure confidence in Quality systems including:
- Support establishing Quality Agreements with clients consistent with Global standard.
- Ensure communications with client are maintained consistent with Quality Agreement and positive client experience
- Support required client audits and provide observation responses consistent with timeline commitments
- Support Compliance Documentation and Licensing
- Establish a calendar to provide visibility to compliance documentation requirements
- Generate and provide required documentation to clients and Regulatory authorities
- Other duties, as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Strong understanding of cGMP's and concepts in several quality systems.
- Demonstrated ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
- Strong oral and written communication skills.
- Ability to negotiate needed actions and manage difficult interactions effectively.
- Knowledge of computerized support tools and software for audit tracking and reporting.
- Demonstrated knowledge of root cause/trend analysis/risk analysis.
- Demonstrated knowledge of quality processes and compliance.
- Demonstrated ability to multi-task and work on several projects and problems
- Ability to work under only general direction
- Ability to independently determine and develop approach to solutions
EDUCATION/EXPERIENCE:
- BA/BS in Biology, Chemistry or similar Science education. MS degree preferred
- 5+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of 3 years of experience within Biopharmaceutical industry
- Prior auditing experience preferred
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