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

Role Summary

The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen RTP Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of shop floor support ensuring critical steps are executed according to batch records and procedural requirements, exceptions review and approval, and responding to operational needs that require QA approval.

Responsibilities

• Ensures product documentation and other documents supporting batch execution are compliant and determine 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 processes including thorough root cause analysis and well-justified rationale to support conclusions
• Actively monitors applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency
• Supports Quality Management and Operations staff in the coordination, preparation for, and follow-up of internal/external audits and inspections as required
• Assists QA Management in day-to-day implementation of Quality Management Systems required to maintain cGMP compliance, ensuring safety, efficacy, and purity of Biogen products
• Supports and/or assists in GxP quality systems-related training, providing mentorship and training within and across functions
• Other job duties as assigned

Qualifications

• Bachelor‚Äôs 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

Education

• Bachelor‚Äôs degree preferably in a field of science or biotechnology, or related