Associate III, Quality Assurance (On The Floor, Swing Shift)

Role Summary

The QA Associate III has working knowledge and the ability to apply technical principles in quality and compliance activities. They understand Biogen Quality Systems, GxP regulations, and internal SOPs, and work to identify and resolve compliance concerns. They function effectively both independently and in a team across multiple business areas and levels, adhering to site and corporate policies, cGMP, safety, and environmental guidelines.

Responsibilities

• Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. This includes review and approval of BPRs, PRCDs/WIs, Formulas, Recipes, Validity Rules, MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; on the Manufacturing floor record review and observations, WORCs, inspection readiness walkthroughs, and oversight of Manufacturing operations.
• Support resolution of technical and compliance issues/gaps of low complexity.
• CAPAs can be assigned and closed based on understanding of CAPA intent and review/approval of the associated document (e.g., PRCD) at management discretion/oversight.
• Assist Quality Assurance Management with day-to-day implementation of Quality Management Systems required to maintain cGMP compliance and ensure product safety, efficacy, and purity; provide training within and across functions as applicable.
• Approximately 50% of time spent on the manufacturing floor; other duties as assigned.

Qualifications

• Required: Bachelor’s Degree in life sciences or related.
• Required: Minimum of 2 years of experience in a quality assurance position within a GMP pharma or biotech manufacturing environment.
• Required: Ability to work effectively independently and within a team across all business areas and levels locally and globally.
• Required: Excellent written, verbal, and interpersonal communication skills.
• Required: Familiarity with downstream process manufacturing.
• Preferred: Previous relevant industry experience in a GMP manufacturing environment.
• Preferred: Experience with column packing or reviewing column pack binders.

Skills

• Strong communication and collaboration abilities to resolve issues and coordinate with cross-functional teams.
• Proficiency in interpreting and applying regulatory and quality system requirements.

Education

• Bachelor’s Degree in life sciences or related field

Additional Requirements

• On-site, full-time role with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule (swing shift)