Sr. Associate , Quality Assurance; Floor Parenteral Filling, Nights

Sr. Associate I, Quality Assurance (On The Floor Parenteral Filling, Nights)

This job is with Biogen, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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

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.

• 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 rationale supporting 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

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.

• 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 skills and detail oriented aptitude
• Ability to develop innovative/creative solutions to issues of moderate complexity
• Excellent oral and written communication skills

Job Level: Professional

The base compensation range for this role is: $79,000 – $103,000. 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.

• 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

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