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Senior Quality Specialist
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-10-11
Listing for:
Hw3 Llc
Full Time
position Listed on 2026-10-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
- 12 month initial contract - Extention likely up to 3 years
- Up to $69 per hour - W2 Only
- Lead and support quality activities including deviations, CAPAs, change controls and investigations.
- Review and approve GMP documentation, procedures and quality records.
- Support batch release, product quality and manufacturing activities where required.
- Work closely with Manufacturing, Engineering, Validation and QA teams to ensure GMP compliance.
- Provide guidance on quality standards, processes and regulatory requirements.
- Support continuous improvement and ensure timely resolution of quality issues.
- 5+ years' experience within a GMP pharmaceutical/biotech environment
. - Strong experience across QA, deviations, CAPA and change control
. - Experience supporting manufacturing and/or commercial operations is highly desirable.
- Strong knowledge of GMP, FDA/EMA regulations and quality systems
. - Excellent communication and stakeholder management skills.
Position Requirements
10+ Years
work experience
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