Senior QA Specialist – Batch Review

Are you a Batch Record expert? Want the next step in your career? Look no further!


INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the third year in a row, INCOG is the perfect place to continue building your career.


Working closely with the QA Manager, the Senior QA Specialist will be instrumental in supporting major QA programs. The role will also involve:

  • Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product, and train other QA personnel on surveillance oversight and on-the-floor Batch Record review requirements. Create and report batch specific metrics to site leadership.
  • Provide Client support with respect to Batch Records and support the authoring, reviewing and approving of various SOPs & Work Instructions.
  • Participate in operations investigations for determining root cause and assessing mitigations for Major and Critical deviating events, and support Quality Systems with batch impacting deviations.


The ideal candidate will a Bachelor’s Degree in Chemistry, Biology, Biochemistry, Microbiology or related discipline. Alongside that, you’ll also have around 7 years experience working in a GMP environment, and significant experience working with aseptic processing in cleanroom and/or isolator environments.

Intrigued? Send us your resume at apply@leadcandidate.com or you can find the full job specification here: Senior QA Specialist (Batch Record Review) – INCOG.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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