Associate III, Quality Assurance

Biogen, Inc.; Northern (KY); Hybrid; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Vacation and holidays

Job summary

Biogen, Inc. is seeking a QA Associate III to apply strong knowledge of cGMP requirements and Biogen Quality Systems to support compliant manufacturing operations.

You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. This role requires sound judgment and the ability to work independently while collaborating with Quality,

Qualifications

• 2+ years of experience in a quality GMP biopharma or pharma environment.
• Working knowledge of GxP regulations and cGMP requirements.
• Strong understanding of quality systems and manufacturing processes.

Responsibilities

• Review and approve batch and cell bank disposition documentation for cGMP compliance.
• Review executed BPRs, PRCDs/WIs, formulas, recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs and PARs.
• Perform manufacturing-floor record reviews, observations and inspection-readiness walkthroughs.
• Provide quality oversight and regulatory/compliance guidance to manufacturing operations.

Skills

GxP knowledge

cGMP experience

Regulatory knowledge

Quality focus

Documentation review

Communication skills

Education

Bachelor’s Degree in life sciences

Job description

About This Role

As a QA Associate III, you will apply strong knowledge of cGMP requirements, Biogen Quality Systems, internal procedures and your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. You will partner across Quality, Manufacturing and PO&T to identify and resolve quality and compliance concerns, support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support, including root cause and impact assessments, and may complete selected minor investigation or GCC assessment activities after demonstrating the required competencies and with management oversight. This individual contributor role requires sound judgment, mature situational leadership and the ability to work independently while collaborating across functions and organizational levels.

What You’ll Do

• Review and approve batch and cell bank disposition documentation for cGMP compliance and product acceptability
• Review executed BPRs, PRCDs/WIs, formulas, recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs and PARs
• Perform manufacturing-floor record review, observations, WORCs and inspection-readiness walkthroughs
• Provide quality oversight of manufacturing operations and technical consultation on regulatory and site-procedure requirements
• Support resolution of technical and compliance issues or gaps of low to moderate complexity
• Support the QA Lead for NPI technology transfers and restart programs
• Provide technical writing, investigation support, root cause analysis and impact assessment
• Support CAPA closure and review or approval of associated documentation with management oversight
• Assist with implementation of Quality Management Systems and GxP quality-systems training
• Communicate quality issues, recommendations and decisions across Quality, Manufacturing, Engineering, Warehouse, and other functions

Who You Are

You are a detail-oriented quality professional who applies sound judgment, regulatory knowledge and a practical understanding of manufacturing to protect product quality. You communicate complex information clearly, adapt to changing priorities and build productive cross-functional partnerships to resolve issues and maintain compliance.

Required Skills

• Bachelor’s Degree required, preferred in a life science discipline
• 2+ years of related experience working in a quality GMP biopharma or pharma environment
• Working knowledge of GxP regulations, cGMP requirements and relevant FDA/EMA expectations
• Understanding of quality systems, quality concepts and manufacturing processes
• Strong organization, prioritization and multi-tasking skills
• Excellent written, verbal and interpersonal communication skills

Preferred Skills

• Investigation, root cause analysis, impact assessment and technical writing skills including demonstrated competency in minor investigations, CAPA documentation or GCC assessments
• Experience reviewing controlled manufacturing and disposition documentation
• Understanding of biopharma or pharma manufacturing processes

Job Level

Professional

Additional Information

The base compensation range for this role is: $69,000.00-$90,000.00 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.

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.

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.