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Quality Validation Specialist

2 months ago

Fishers, United States INCOG BioPharma Services Full time

Quality Validation Specialist


INCOG BioPharma is looking for a Quality Validation Specialist to join their QA team This individual will be working closely with the Manager of QA and will be instrumental in ensuring site compliance with regulations, industry standards (ISPE, PDA, ASTM, etc), and organizational SOPs. The Quality Validation Specialist will provide support with the review and approval of lifecycle documentation, protocols, summary reports, and change controls.


There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.


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 patients for yourself, INCOG's clients, and patients.


Role Responsibilities:


  • Review documentation for compliance and Quality approval, including but not limited to: equipment and software (process equipment, computerized systems, facilities, utilities, laboratory equipment as needed) commissioning, IQ/OQ/PQ protocols and reports, equipment and software validation lifecycle documents (e.g. URS, TM, etc.), cleaning validation protocols and reports, and process validation protocols and reports.
  • Provide Quality oversight to the periodic qualification evaluation (PQE) program to ensure timeliness of execution and documentation completion.
  • Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
  • Ability to manage multiple projects in a fast-paced environment.
  • Provide support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed.


Education and Experience Requirements:


The ideal candidate will have:


  • Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
  • Minimum of 2 years of biopharma industry experience with increasing responsibilities in Commissioning, Qualification, and Validation.
  • Excellent written and verbal communication skills.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
  • Experience with executing or providing oversight for CQV activities for FDA/EMA regulated facilities.
  • Experience with CQV activities for aseptic manufacturing facilities or clean utilities (e.g. Water for Injection, Clean Steam, etc.).
  • Experience utilizing electronic validation execution systems (e.g. KNEAT, ValGenesis).


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.