The role
You will review batch records — the documentary evidence that a medicine was made the way we said it would be.
What you will do
- Review executed batch records for completeness, accuracy and compliance
- Identify and route discrepancies for investigation
- Support timely disposition of batches to meet supply commitments
- Track and trend documentation error types to drive improvement
- Contribute to batch record design improvements
What success looks like at 12 months
Review cycle times support release schedules, error trends are visibly reducing, and your findings are accepted without argument because they are right.
What we require
- GMP documentation experience
- Genuinely forensic attention to detail
- Ability to sustain focus through long, complex documents
- Clear communication of findings to manufacturing
What we would like, but will teach you
- Biologics batch record review experience
- Deviation writing experience
- Experience improving a document that people kept getting wrong
If you meet the required list, apply. We cap the preferred list at four items on purpose, and we would rather read an application from someone who is 70% there and hungry.
Onsite at Devens, MA. Site-based office roles are onsite three days a week; lab, plant and quality roles are onsite by nature.
Pay and rewards
This role sits at grade 6, with a base range of $80,000 – $104,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our largest manufacturing site, running drug substance 24/7. More about our locations.
Accommodations
Need an adjustment to apply or interview? Email accommodations@ingenbiotech.example. It goes to a separate team and is never shared with the hiring manager. What we can arrange.
Applications are not enabled on this demonstration site
On a live InGen careers site this button would open a one-page application: a CV and three short questions, about twelve minutes, no account required and no cover letter.