Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Waltham, MA.
- Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.
- Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.
- Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.
- Clearly communicate issues as applicable to CMOs and Quality management in a timely basis
- Review and approve documentation related to production and / or packaging operations as assigned.
- As appropriate attend project meetings.
Skills and Requirements:
- Minimum bachelor's degree in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science)
- Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies)
- Experience and working knowledge on Small molecules chemistry, tablets and capsules.
- Experience building relationships and working with CMOs
- Working knowledge ICH/EMA/FDA regulations
- Competency in MS Office, Adobe Acrobat, Veeva, Trackwise
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.