Quality Control Specialist
Proclinical is currently recruiting for a Quality Control Specialist with a pharmaceutical company located in Boston, MA.
- Responsible (authoring, initiation, and review) for quality records (change controls, CAPAs, deviations, SOPs, risk assessments, etc.), specifications, and justification of specification reports.
- Responsible for coordinating QC impact assessments as part of quality records.
- Maintains ad hoc meetings with the Specification Review Board, a cross-functional team, to support the lifecycle of commercial programs
- Supports multiple CMC program teams by providing documents in a timely manner for: product and product release, stability programs, extension of shelf life for products, and commercial launch.
- The role requires regular interactions with senior members of cross functional teams and provides project management and Subject Matter Expert (SME) knowledge for product specifications (API, drug product, intermediates, and potentially critical starting materials)
- Coordinates with Quality and Program Managers to provide project updates, workflows, and timelines. Maintains the QC department dashboard to show the current status of programs/deliverables.
- Perform data verifications (data integrity review), support analytical method validations, and perform statistical analysis of data, as needed.
Skills and Requirements:
- B.S. in chemistry or a related discipline
- 3+ years of experience in an industrial setting, preferably in a cGMP environment as it pertains to the biopharmaceutical industry
- Prior experience with relevant ANVISA, EMA, FDA, ICH, and JP guidelines as it pertains to drug substance and drug product specifications
- Knowledge of regulatory processes in relation to filings and marketing applications for Module 3 (amendments, CTD, IMPD, IND, NDA, MAA, etc.)
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.