QA Sr. Specialist GMP

Integrated Resources, Inc

22 hours ago

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Title: QA Sr. Specialist GMP
Work Location: Cambridge, MA 02139 (Hybrid)
Contract Duration: 6 Months
Pay Rate: $60 - $65 Hourly 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.

QA Sr. Specialist GMP · Integrated Resources, Inc