Job Description
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.
Numbers & Facts
| Location | Cambridge, MA |
| Salary | $60–$65 Per Hour |
Skills
Analysis Skillsunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Design Verificationunmatched
Detail Orientedunmatched
Documentationunmatched
Drug Productsunmatched
Establish Prioritiesunmatched
FDA Requirementsunmatched
File Maintenanceunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Government Regulationsunmatched
GxPunmatched
ICH Regulationsunmatched
Interpersonal Skillsunmatched
Manufacturingunmatched
Microsoft Officeunmatched
Microsoft Product Familyunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Reviewsunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Supply Chainunmatched
Team Playerunmatched
Time Managementunmatched
Verification Plansunmatched
Word Processingunmatched
Writing Skillsunmatched
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