QA Sr. Specialist GMP

Title:

QA Sr. Specialist GMPRemote/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 & Eudra Lex 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.