This contractor opportunity is for a Quality Auditor - Scientific - II (Associate) within the Global Development Quality Operations - Drug Product (GDQ Ops) organization. The GDQ Ops team provides critical quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products, ensuring continuous GMP-compliant clinical supply for both internally and externally manufactured supplies. Working under the direction of GDQ-Ops Supervision, the contractor will play a pivotal, supportive role in quality assurance oversight, product release, document management, and compliance projects within a dynamic, fast-paced R&D environment.
Responsibilities- Perform independent quality review and approval of batch records, testing data, and related documents to make independent batch release or reject decisions.
- Conduct independent auditing, review, and approval of complex document types, including deviations, investigations, analytical method validations, method transfers, and certificates of analysis.
- Support compliance activities such as site readiness, health authority audits, and Corrective and Preventive Actions (CAPAs).
- Collect, prepare, and analyze data to support quality system metrics and planning initiatives.
- Perform document management activities, including cataloging records for long-term storage according to retention policies.
- Develop, write, technically edit, or review procedures and other standard documents under Good Manufacturing Practice (GMP) guidelines.
- Support projects aimed at continuous quality improvement, utilizing project management skills as needed.
- Provide meeting coordination, facilitation, scribing, and clear communication across teams.
- Ensure strict compliance with applicable GMP regulations, ICH guidelines, and company policies.
- Education
- Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (such as engineering, chemistry, biology, biochemistry, or microbiology).
- Recent graduates can be considered for this role.
Experience- A minimum of 3 years of experience is preferred.
- Experience must be within the pharmaceutical, biotechnology, chemical, medical device, or a closely related industry.
- Demonstrated knowledge of R&D or clinical supply areas, processes, and preferred drug product manufacturing and testing.
- Background in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, or regulatory.
- Strong foundational knowledge and expertise in Good Manufacturing Practice (GMP) or related drug regulations.
Additional Information- Candidates must possess strong leadership, collaboration, teamwork, negotiation, and workload management skills to handle rapidly changing R&D needs.
- Proven ability to work cross-functionally and across various sites with all levels of staff and management is required.
- Qualified candidates must be proficient with the Microsoft Suite (Word, Excel, PowerPoint, Teams) and show a strong ability to adapt to learning other electronic day-to-day work systems.
