QA Associate GMP

Location: Cambridge, Massachusetts, United States
Salary: competitive
Job Type: Contract
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Job Title: QA Associate GMP

Location: Cambridge, MA

Duration: 6 months, possibility of extension

Compensation: Varies depending on experience

Benefits: Real Staffing offers medical, dental, vision, 401k, voluntary life insurance, short term/long term disability

Description:

  • 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 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.
  • 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
  • To have been involved on a device development project before as QA
  • Signed off on design development plan, completed design verification, approved DHF deliverables
  • Good understanding of FDA and EMA regulations and guidelines
  • Excellent organizational, communication, and interpersonal skills.
  • Preferred Quality Drug Substance manufacture experience

Sthree US is acting as an Employment Business in relation to this vacancy.

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