Quality Control Compliance Specialist

2 days ago

Fishers, United States INCOG BioPharma Services Full time

QC Compliance Specialist


INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Control Compliance Specialist. They are looking for a Quality Control Compliance Specialist who will help with the testing experience. The QC Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience.


This role will support laboratory processing of finished product, incoming materials and stability sample release. Additionally, they will lead projects for continuous improvements in methods or method execution.


At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.


Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for yourself, INCOG's clients, and patients.


Job Functions:


  • Perform in-depth technical data review of all analytical and microbiological testing performed on finished products - in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs. Review includes both technical review of method performance as well as confirming data integrity elements, e.g. good documentation practices, audit trail reviews, etc.
  • As assigned, perform, and drive in-depth laboratory investigations, deviations, and change controls to completion. Determine root cause and propose appropriate CAPAs.
  • Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories.
  • Perform technical writing such as drafting specifications, protocols, SOPs, templates, etc. Revise and improve analytical methods, protocols, and associated SOPs.
  • Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.
  • Assist in the management of method transfers into the QC laboratory. Work with QC and QA to ensure success of these transfers.
  • As a part of the employee's job requirements, the employee may be required to handle waste including hazardous waste. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.


Education and Experience Requirements:


  • Degree in Chemistry, Biology or Life Sciences.
  • 5-7 years' experience in GMP regulated industry.


Why INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations


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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