Sr. Associate II, Quality Assurance
Biogen
4 hours ago
On-site
Triangle, NC
Operations
What You’ll Do
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact; conduct investigations and thorough reviews; provide feedback to the department owner; analyze defects to identify potential process attribution; write/review and approve minor and major deviations.
- Lead, coordinate, and ensure timely completion of Annual Product Reviews.
- Participate in cross-functional risk assessments to identify, evaluate, and mitigate risks to product quality, patient safety, and regulatory compliance.
- Data integrity governance: Maintain ALCOA+ aligned governance; perform data integrity risk assessments (manufacturing, laboratory, quality systems); ensure data lifecycle management (generation through archival/retrieval); develop/deliver data integrity and GMP training; monitor regulatory trends and incorporate best practices.
- Batch Record Review and 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 use and/or product release.
- 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 technical problem solving.
- Assist QA Management with day-to-day implementation of Quality Management Systems to maintain cGMP compliance and product safety/efficacy/purity.
- Support GxP quality systems-related training and provide mentorship/training across functions.
Required Skills
- Bachelor’s degree (preferred in life science) or Associate’s degree plus 7+ years of related experience.
- Minimum 5 years relevant Quality Assurance experience in GMP pharmaceutical/biotech manufacturing.
- Experience reviewing/approving batch records, master records, SOPs, and technical documents.
- Deep understanding of data integrity.
- Experience conducting and explaining investigations to quality management and regulatory bodies.
- Experience working in manufacturing (QA oversight or manufacturing operator).
- Advanced understanding of global quality systems and GxP regulations.
- Ability to work effectively independently and in teams across local/global business areas.
- Excellent written/verbal/interpersonal communication to summarize complex topics, make recommendations/decisions, and collaborate cross-functionally.
Preferred Skills
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule).
- Experience supporting product disposition.
- Strongly preferred: experience conducting and explaining investigations to quality management and regulatory bodies.
Benefits
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs (fitness reimbursement); Short- and Long-Term Disability insurance; at least 15 days paid vacation plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; 80 hours sick time/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.
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact; conduct investigations and thorough reviews; provide feedback to the department owner; analyze defects to identify potential process attribution; write/review and approve minor and major deviations.
- Lead, coordinate, and ensure timely completion of Annual Product Reviews.
- Participate in cross-functional risk assessments to identify, evaluate, and mitigate risks to product quality, patient safety, and regulatory compliance.
- Data integrity governance: Maintain ALCOA+ aligned governance; perform data integrity risk assessments (manufacturing, laboratory, quality systems); ensure data lifecycle management (generation through archival/retrieval); develop/deliver data integrity and GMP training; monitor regulatory trends and incorporate best practices.
- Batch Record Review and 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 use and/or product release.
- 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 technical problem solving.
- Assist QA Management with day-to-day implementation of Quality Management Systems to maintain cGMP compliance and product safety/efficacy/purity.
- Support GxP quality systems-related training and provide mentorship/training across functions.
Required Skills
- Bachelor’s degree (preferred in life science) or Associate’s degree plus 7+ years of related experience.
- Minimum 5 years relevant Quality Assurance experience in GMP pharmaceutical/biotech manufacturing.
- Experience reviewing/approving batch records, master records, SOPs, and technical documents.
- Deep understanding of data integrity.
- Experience conducting and explaining investigations to quality management and regulatory bodies.
- Experience working in manufacturing (QA oversight or manufacturing operator).
- Advanced understanding of global quality systems and GxP regulations.
- Ability to work effectively independently and in teams across local/global business areas.
- Excellent written/verbal/interpersonal communication to summarize complex topics, make recommendations/decisions, and collaborate cross-functionally.
Preferred Skills
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule).
- Experience supporting product disposition.
- Strongly preferred: experience conducting and explaining investigations to quality management and regulatory bodies.
Benefits
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs (fitness reimbursement); Short- and Long-Term Disability insurance; at least 15 days paid vacation plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; 80 hours sick time/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.