QA Associate GMP
Job Title: QA Associate GMP
Location: Cambridge, MA
Duration: 6 months, possibility of extension
Compensation: Varies depending on experience
Benefits: Real Staffing offers medical, dental, vision, 401k, voluntary life insurance, short term/long term disability
- Review of event documentation such as Batch records, Exceptions, and Regulatory filings
- Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
- Support design development plan including design verification and DHF deliverables
- Build and maintain Product Specification Files (PSF) for program
- Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
- Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
- Demonstrated teamwork, initiative, and problem-solving skills
- Ability to prioritize and work independently with minimal supervision
- Ability to accurately determine deadlines and ask for help if needed
- Detail oriented with solid problem-solving acumen.
- Proficient with computers and word processing software (i.e., Microsoft Office products)
- Minimum, a BS degree in life sciences, engineering, or related field
- Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
- To have been involved on a device development project before as QA
- Signed off on design development plan, completed design verification, approved DHF deliverables
- Good understanding of FDA and EMA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.
- Preferred Quality Drug Substance manufacture experience
Sthree US is acting as an Employment Business in relation to this vacancy.