# Sr Associate I, Quality Assurance Operations

Hiring organization: [Biogen](https://career.thegoodapps.co/organizations/biogen)

Canonical page: https://career.thegoodapps.co/jobs/8930b51d-32d4-4506-8028-c28f9732b095

Listed on Biogen's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Mid
- Location: Research Triangle Park, NC
- Salary: 81000 – 105000 USD per year

## Summary

A quality assurance professional overseeing compliance and operations at a biotech manufacturing facility, reviewing batch records, conducting investigations, and coaching teams to maintain GMP standards. This role suits someone with pharma QA experience who wants to deepen their expertise while mentoring others.

_Our summary, not Biogen's wording._

## Skills named

Corrective And Preventive Action (CAPA), Quality Management Systems, Root Cause Analysis

## Required

- Bachelor's degree (preferably in life sciences)
- Minimum 4 years of quality assurance experience in GMP pharmaceutical or biotech manufacturing
- Experience reviewing and approving batch records
- Experience conducting investigations and presenting findings to quality management and regulatory bodies
- Advanced understanding of global quality systems and GxP regulations
- Ability to work independently and collaboratively across organizational levels

## Nice to have

- Drug substance manufacturing experience
- Biologics experience
- Contract manufacturing organization experience
- Product disposition support experience
- Experience explaining investigations to regulatory bodies

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Research-Triangle-Park-NC/Sr-Associate-I--Quality-Assurance-Operations_REQ23783