GMP Quality Assurance Specialist in Cambridge, Massachusetts
Posted 08/14/20

AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance. 

 

THE TEAM YOU WILL BE JOINING:

  • Industry-leading, bio-pharmaceutical company, listed top 40 of Global Innovation
  • Innovator in scientific breakthroughs and has been at the frontier each decade
  • Vision and passion around revolutions in biology for human health
  • Committed to their team, discovery, a sense of urgency, open culture, and best in class performance

 

WHAT THEY OFFER YOU:

  • Be a part of a committed and most forward-thinking team in their field
  • Work alongside a diverse and culturally aware environment with opportunities for employee development and networking
  • Year-round employee wellness programs and extensive employee health/safety programming
  • Community events that promote education, learning, and wellness along with arts and cultural institutions
  • Opportunity to collaborate on company-wide community service days and volunteerism

 

WHERE THIS POSITION IS LOCATED:

  • Cambridge, MA

 

WHY THIS ROLE IS IMPORTANT:

  • 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

 

THE BACKGROUND THAT FITS:

  • 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
  • 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.
  • 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)

 

  • Employee Type: Contract
  • Location: Cambridge, Massachusetts
  • Date Posted: 08/14/20
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Apply Today!

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