Sr Associate I, Quality Assurance Operations
Biogen
5 hours ago
On-site
Triangle, NC
Operations
What You’ll Do
- Batch Record Review impacting Product Disposition: Review quality-related documents (e.g., production records, procedures, work instructions, raw data, in-process testing) for compliance and determine acceptability for GMP production and/or product release.
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact; conduct investigations, thoroughly review findings, provide feedback to the department owner, and analyze defects to identify potential process contributors.
- Controlled Document Workflows: Review GMP controlled documents to ensure changes/reasons are accurately reflected, comply with applicable regulations and company directives, do not adversely impact product quality, and support appropriate release dates.
- Conduct area walkthroughs and work observations to identify compliance gaps; collaborate with Manufacturing and area SMEs on corrective actions.
- Support resolution of technical and compliance issues/gaps of moderate complexity; help implement Quality Systems/system improvements and provide technical problem-solving.
- Support day-to-day implementation of Quality Management Systems to maintain cGMP compliance and ensure product safety, efficacy, and purity.
- Support and/or assist GxP quality systems-related training; provide mentorship and training across functions.
Required Skills
- Bachelor’s degree (preferred in life science)
- 4+ years of relevant Quality experience in a GMP pharmaceutical/biotech manufacturing environment
- Experience reviewing and approving batch records
- Experience conducting and explaining investigations to quality management and regulatory bodies
- Advanced understanding of global quality systems and GxP regulations
- Ability to work independently and cross-functionally across global/local business areas
- Strong written, verbal, and interpersonal communication skills for summarizing complex issues and advising Quality Management/regulatory bodies
Preferred Skills
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule)
- Experience supporting product disposition
- Experience conducting/explaining investigations to quality management and regulatory bodies (strongly preferred)
Benefits (explicitly listed)
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness (fitness reimbursement); Short- and Long-Term Disability
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); Up to 12 company holidays + 3 personal days
- Sick time (80 hours/year); Paid Maternity and Parental Leave; 401(k) with company match
- Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation
- Batch Record Review impacting Product Disposition: Review quality-related documents (e.g., production records, procedures, work instructions, raw data, in-process testing) for compliance and determine acceptability for GMP production and/or product release.
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact; conduct investigations, thoroughly review findings, provide feedback to the department owner, and analyze defects to identify potential process contributors.
- Controlled Document Workflows: Review GMP controlled documents to ensure changes/reasons are accurately reflected, comply with applicable regulations and company directives, do not adversely impact product quality, and support appropriate release dates.
- Conduct area walkthroughs and work observations to identify compliance gaps; collaborate with Manufacturing and area SMEs on corrective actions.
- Support resolution of technical and compliance issues/gaps of moderate complexity; help implement Quality Systems/system improvements and provide technical problem-solving.
- Support day-to-day implementation of Quality Management Systems to maintain cGMP compliance and ensure product safety, efficacy, and purity.
- Support and/or assist GxP quality systems-related training; provide mentorship and training across functions.
Required Skills
- Bachelor’s degree (preferred in life science)
- 4+ years of relevant Quality experience in a GMP pharmaceutical/biotech manufacturing environment
- Experience reviewing and approving batch records
- Experience conducting and explaining investigations to quality management and regulatory bodies
- Advanced understanding of global quality systems and GxP regulations
- Ability to work independently and cross-functionally across global/local business areas
- Strong written, verbal, and interpersonal communication skills for summarizing complex issues and advising Quality Management/regulatory bodies
Preferred Skills
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule)
- Experience supporting product disposition
- Experience conducting/explaining investigations to quality management and regulatory bodies (strongly preferred)
Benefits (explicitly listed)
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness (fitness reimbursement); Short- and Long-Term Disability
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); Up to 12 company holidays + 3 personal days
- Sick time (80 hours/year); Paid Maternity and Parental Leave; 401(k) with company match
- Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation