An established Connecticut-based pharmaceutical company is looking for a driven Quality Specialist to join its growing team based in the Greater Hartford Area!
Reporting to the Senior Director of Quality, the Quality Specialist will drive GMP compliance and collaborate with key stakeholders on the manufacturing floor.
The QA Specialist will have the following responsibilities:
Working independently and under minimal supervision, the QA Specialist will assure products are manufactured in compliance with internal, regulatory, and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.
- Review and may approve documents such as SOP's, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports
- Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
- Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
- Perform product complaints investigations
The ideal candidate will have the following skill set:
- 3+ years of QA experience, with background in GMP manufacturing
- Bachelors degree in a life science related field required (advanced degree preferred)
