Title: QA Sr. Specialist GMP
Remote/Onsite: Cambridge, MA Hybrid
Pay – $60/hr. – $65/hr. on w2
Duties
- 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 client program
Skills
- 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.
- Ability to work effectively in a team environment with great organization skills.
- Ability to independently analyze and reconcile moderate to complex issues.
- Must have demonstrated initiative and accountability in a fast-paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e., Microsoft Office products)
Education
- 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
- Good understanding of FDA and EMA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.