QC Associate III-IV
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:
AGC is searching for an experienced Associate to join AGC Biologics expanding Quality Control team. This Associate will onboard new equipment, author and edit Quality System procedures, drive change controls to completion and lead continuous improvement initiatives. Working with cross-functionally with QA, validation, and engineering groups, the QC Associate will be responsible for meeting QC timelines related to deliverables such as equipment onboarding, change controls, and execution of equipment validation protocols and reports.
PRINCIPAL RESPONSIBILITES:
- Coordination of onboarding activities including assisting in authoring, reviewing and executing protocols
- Execute equipment support activities including maintenance and upkeep of equipment database systems.
- Coordinate vendor support for troubleshooting and onsite activities.
KNOWLEDGE, SKILLS & ABILITIES:
- Proven scientific and technical ability to design and execute validation experiments
- Proven technical writing ability to author protocol and reports
- Demonstrated knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals.
- Must be a highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
- Excellent analytical, communication and data management skills
- Ability to understand analytical/technical data.
- Good organizational skills with attention to detail.
- Ability to interact constructively with co-workers.
EDUCATION/EXPERIENCE:
- BS in Life Sciences discipline such as Biochemistry, Chemistry, Biology or related field required
- Minimum of 5+ years of experience in the biotechnology or pharma industry with experience in biologics
- A strong background in equipment qualification and validation is highly desired.
- Experience working in a QC environment.
- Experience with relevant analytical lab equipment and computers.
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