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 the companies 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. Pay ranges between 55-60/hr based on experience