This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule

About This Role

The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities: (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval.

WhatYou'llDo

• Ensures Product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution

• Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions

• Actively monitors the applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency

• Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required

• Assists QA 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

• Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions

• Other job duties as assigned

Who YouAre

You are task oriented and focused on continuous improvement. You ask copious questions and excel at root/cause analysis and troubleshooting. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

Required Skills

• Bachelor's degree preferably in a field of science or biotechnology, or related

• Minimum of 4 years of experience working in a quality assurance capacity in a biotech or pharmaceutical manufacturing environment

• Experience working in a parenteral filling OR aseptic environment OR experience working with isolators

• Experience working on the floor and reviewing and approving batch records

• General understanding of relevant FDA/EMA regulations and compliance

• Strong organizational skillsand detail oriented aptitude

• Ability to develop innovative/creative solutions to issues of moderate complexity

• Excellent oral and written communication skills

Additional Information

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 onto 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.