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Quality Assurance Associate

4 months ago

Fishers, United States INCOG BioPharma Services Full time

QA Associate


WHO?


INCOG Biopharma Services is seeking a Quality Assurance professional to oversee and support fill/finish activities (e.g. formulation, filing, inspection, packaging) at their state-of-art CDMO during this exciting time of growth. 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.


WHAT?


  • Review and approve documentation for Quality approval (batch record review, logbooks, work orders, procedures, etc.), supporting others where possible.
  • Collaborate with other departments on investigations to resolve equipment and process-related deviations. Evaluate the scope and impact of deviating events, implementing CAPAs or escalations where necessary.
  • Provide investigative support via the use of Root Cause Analysis tools, report writing, and mitigation development using risk analysis. Use technical skills and applied statistics to analyze/ track deviations to identify variability/ error sources.


YOU


The ideal candidate will have a Bachelor’s degree in a Science filed (Chemistry, Biology, Biochemistry, Microbiology, etc), as well as:


  • At least 2 years’ experience working within the Quality department of a GMP Manufacturing environment, or as an operator within pharmaceutical manufacturing.
  • Knowledge of regulations and quality systems such as deviations, non-conformances, CAPAs, etc.
  • Hands-on experience with aseptic manufacturing is preferred, but is note essential.


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