The role
You will apply the quality system in practice — reviewing, approving, questioning and keeping the site honest about its own standards.
What you will do
- Review and approve GMP documentation including procedures and records
- Support deviation, change control and CAPA processes
- Provide quality guidance to operational teams on the floor
- Participate in audits and inspection preparation
- Monitor quality metrics and escalate adverse trends
What success looks like at 12 months
Your reviews are timely and add value rather than delay, operations consult you before acting, and your documentation withstands audit.
What we require
- Experience in a GMP or comparably regulated environment
- Solid understanding of documentation and change control principles
- Ability to challenge constructively and hold a position
- Clear written communication
What we would like, but will teach you
- Biologics or sterile manufacturing quality experience
- ASQ certification
- Military quality assurance representative experience — a strong fit
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.
Military quality assurance representatives and aviation QA backgrounds transfer well here.
Onsite at Bloomington, IN. 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 $70,000 – $91,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our drug product and sterile fill-finish site. 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.