Associate III, Quality Assurance (Swing Shift)

at  Biogen

Job Description
This is a full time on-site position with the working hours of 12PM (noon) to 12AM (midnight) on a rotating 2,2,3 schedule

PREFERRED SKILLS

• Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations.
• Experience reviewing and approving production batch records, and deviations.
  Additional Information

ABOUT THIS ROLE

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management.

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, 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. 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.
• Control and release of equipment from maintenance, validation, change control and product changeover.
• Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions.