Associate, Quality Assurance (Process Team)

Your Role: Associate, Quality Assurance (Process Team)

Responsibilities:
- Serve as QA SME for assigned process areas, ensuring adherence to GMP standards and quality system requirements
- Lead and support deviation investigations, root cause analysis, and CAPA development
- Manage and approve quality records (Deviations, Change Controls, CAPAs, Impact Assessments) within Veeva, ensuring timely closure
- Partner cross-functionally with TS/MS, Engineering, Production, and Quality Control to identify risks and drive Right First Time (RFT) improvements
- Support audit readiness and regulatory inspections, including SOP development, technical reviews, and quality governance activities

What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s Degree in a science-related field (e.g., Biology, Chemistry)
- Required Experience: Experience in pharmaceutical, vaccine manufacturing, or Quality Control environments with increasing technical responsibility (level dependent: P1–P3)
- Top skills: Strong technical problem solving/critical thinking; ability to lead complex quality investigations and documentation

What will give you a competitive edge (preferred qualifications):
- Experience with Veeva, SAP, and Microsoft Office tools
- Prior experience in USDA/FDA regulated manufacturing environments
- Knowledge of Lean/Six Sigma methodologies
- Experience supporting regulatory inspections and audit readiness
- Strong technical writing and documentation skills

Additional Information:
- Travel: Minimal
- Location: Fort Dodge, IA Manufacturing Site

Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching