Sr Associate I, Quality Assurance Operations

What You’ll Do

• Batch Record Review impacting Product Disposition: Review all Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, raw material disposition, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
• Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact. Conduct investigations and perform thorough reviews of the investigations and provide feedback to the department owner. Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect.
• Controlled Document Workflows: Review of GMP controlled documents to ensure changes and reasons are accurately reflected in the workflow, content is compliant with all applicable regulations and company directives, changes will not have an adverse impact to product quality and setting appropriate release dates.
• Complete area walkthroughs and work observations to identify compliance gaps.
• Collaborate with Manufacturing and Area Subject Matter Experts to identify appropriate corrective actions.
• Support resolution of both technical and compliance issues/gaps of moderate complexity.
• Help in implementation of Quality Systems/System Improvements and technical problem solving.
• Assist Quality Assurance 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.
• Support area release, changeovers and equipment release, visual inspection of equipment, shutdown activities, equipment tracking workflows, work order reviews and approvals.
• Other duties as assigned.

Who You Are

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

Required Skills

• Bachelor’s Degree required, preferred in life science
• Minimum 4 years of relevant Quality experience within a GMP pharmaceutical or biotech manufacturing environment
• Experience reviewing and approving batch records
• Experience conducting and explaining investigations to quality management and regulatory bodies
• Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
• Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
• Excellent written, verbal, and interpersonal communication skills required in order to condense complex subjects into key bullet points, articulate recommendations and decisions to Quality Management and regulatory bodies, develop strong networks cross-functionally to drive collaboration, processes and decisions

Preferred Skills

• Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule)
• Experience supporting product disposition
• Experience conducting and explaining investigations to quality management and regulatory bodies is strongly preferred