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

Role Summary

The Senior Quality Associate I provides QA support for Parenteral Filling operations at Biogen RTP, including shop-floor oversight, exceptions review, and QA approvals. This role operates nights on a 2-2-3 rotation and collaborates with Quality Management and Operations to maintain cGMP compliance and product integrity.

Responsibilities

• Ensures product documentation and supporting batch records are compliant and acceptable for cGMP production activities or release of product for further processing and/or distribution
• Drives exceptions to closure with thorough root-cause analysis and well-justified rationale to support conclusions
• Monitors data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency
• Supports Quality Management and Operations in coordinating, preparing for, and following up on internal/external audits and inspections as required
• Assists QA Management with day-to-day Quality Management Systems activities to maintain cGMP compliance and ensure safety, efficacy, and purity of Biogen products
• Supports GxP quality systems-related training and provides mentorship and training across functions
• Other job duties as assigned

Qualifications

• Required: Bachelor’s degree preferably in a field of science or biotechnology, or related
• Required: Minimum of 4 years of experience in a quality assurance capacity in a biotech or pharmaceutical manufacturing environment
• Required: Experience in a parenteral filling OR aseptic environment OR experience with isolators
• Required: Experience on the manufacturing floor reviewing and approving batch records
• Required: General understanding of relevant FDA/EMA regulations and compliance
• Required: Strong organizational skills and detail-oriented aptitude
• Required: Ability to develop innovative/creative solutions to moderately complex issues
• Required: Excellent oral and written communication skills

Education

• Bachelor’s degree in science, biotechnology, or related field (required)

Skills

• Root cause analysis and troubleshooting
• Strong communication and collaboration abilities
• Analytical thinking and problem-solving
• Detail-oriented with strong organizational capabilities
• Ability to work across all levels of the organization