Sr Associate II, Quality Assurance Operations
About The Position
As a Sr. Associate II in Quality Assurance, you will play a pivotal role in overseeing the quality strategy for our assigned internal programs and manufacturing operations at the RTP PHARMA site. You will ensure the coordination of key tactical and operational aspects, supporting batch record review, disposition, investigations, change controls, and handling post-release activities. Your expertise will drive the review and approval of critical documents, including batch reports and technology transfer documents, ensuring compliance with regulatory requirements. Your contributions will be integral to maintaining adherence to Biogen policies, managing quality projects, and interfacing with key partners to uphold regulatory standards.
Requirements
- Bachelor's Degree in Life Science or other related discipline
- Minimum 5 years (or Associate's plus 7 years) of experience working in quality assurance within a pharmaceutical or biotech manufacturing environment
- Experience reviewing and approving batch records
- Well versed in conducting and approving investigations
- Solid understanding of relevant FDA/EMA regulations and compliance
- Strong organizational skills with the ability to multi-task
- Excellent written, verbal, and interpersonal communication skills
- Competency in enterprise computer applications
Nice To Haves
- Drug substance manufacturing and/or release
- Experience working in ASO highly desired
- Experience in clinical label and pack
- Experience in a syringe and/or cartridge manufacturing environment
Responsibilities
- Oversee the Quality strategy for assigned programs and manufacturing operations
- Coordinate with other line functions to ensure tactical and operational aspects within QA
- Support batch record review and disposition, ensuring compliance
- Review and approve investigational reports and GMP documentation
- Drive the review and approval of batch/campaign reports and technology transfer documents
- Assist in the development of Global Quality Systems and provide quality oversight
- Mentor and train peers within the Quality Assurance function
- Participate in audits, inspections, and cross-functional improvement initiatives
- Manage Quality projects and adhere to regulatory licenses and regulations
- Interface with key Quality, tech transfer, and manufacturing partners
- Ensure systems within the Quality Assurance department comply with cGMP standards
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
