Quality Validation Specialist

WHO?

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 and reviewing and approving various organizational documentation.

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 second year in a row, INCOG is the perfect place to continue building your career.

WHAT?

• Review documentation for compliance and Quality approval, including but not limited to: commissioning, IQ/OQ/PQ protocols and reports, validation lifecycle documents, 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.

YOU!

The ideal candidate will have a Bachelor’s Degree (Chemistry, Biology, Biochemistry, Microbiology etc.). They will also have at least 2 years of biopharma industry experience with increasing responsibilities in Commissioning, Qualification, and Validation. Experience with CQV activities for aseptic manufacturing facilities or clean utilities (e.g. Water for Injection, Clean Steam, etc.) is preferred but not required.

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.