QA Sr. Specialist GMP

Title: QA Sr. Specialist GMPRemote/Onsite: Cambridge, MA HybridPay – $60/hr. – $65/hr. on w2DutiesReview of event documentation such as Batch records, Exceptions, and Regulatory filingsProduction record review and Product disposition for drug substance, drug product, device assembly and finished goodsSupport design development plan including design verification and DHF deliverablesBuild and maintain Product Specification Files (PSF) for client program SkillsKnowledge 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 skillsAbility to prioritize and work independently with minimal supervisionAbility to accurately determine deadlines and ask for help if neededDetail 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) EducationMinimum, a BS degree in life sciences, engineering or related fieldMinimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environmentGood understanding of FDA and EMA regulations and guidelinesExcellent organizational, communication, and interpersonal skills.