About This Role
This is a full time, on-site position with M-F business hours
The Sr Associate I, Quality Assurance has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The Sr Associate I QA has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The Sr Associate I QA identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The Sr Associate I QA performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The Sr Associate I QA should be able to work effectively, independently and within a team framework, across multiple business areas and levels of the organization.
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What You'll Do
- Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. This includes but is not limited to Review and Approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, Validity Rules (FRRV/BOM), existing/revised MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; on the Manufacturing floor record review and observations, performing WORCs, performing inspection readiness walkthroughs, oversight of Manufacturing operations; QA representative (support the QA Lead) for NPI Tech Transfers and Restart Programs
- Serve as a technical consultant for quality related issues and assuring compliance with regulatory requirements and site procedures. Supports resolution of both technical and compliance issues/gaps of low to moderate complexity
- Execute activities including technical writing, investigation support (root cause analysis/impact assessment). This includes that CAPAs may be closed based on their understanding of the CAPA intent and review/approval of the associated document (i.e. PRCD) at Management discretion/oversight; may write and/or review/approve Minor investigations/deviations based on demonstration of competencies at Management discretion/oversight; and may review and provide GCC assessments based on demonstration of competencies at Management discretion/oversight
- Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen. Supports and/or assists in GxP quality systems-related training. Provides training within and across functions, as applicable
- Other duties as assigned
Required Skills
- Bachelor's Degree required, preferred in life science
- Minimum 4 years of relevant Quality Assurance experience within a pharmaceutical or biotech GMP manufacturing environment
- Experience conducting and/or supporting investigations and deviations
- Experience authoring, reviewing and approving GMP documentation
- Understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
- Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
- Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes and decisions
- Experience with quality management systems (ex. TrackWise, Veeva)
Preferred Skills
- Experience with change controls
Job Level: Professional
Additional Information
The base compensation range for this role is: $79,000.00-$103,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.