Senior PQA QA Associate – Onsite Manufacturing Quality

Global Technical Talent

West Greenwich (RI)

On-site

USD 33,000 - 37,000

Full time

4 days ago
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Benefits offered by this job

Medical Insurance
Vision Insurance
Dental Insurance
401k Retirement Plan

Job summary

GTT in West Greenwich, RI seeks a QA Senior Associate - PQA for on-site duties across Facilities & Engineering, Process Development, IQA, and Manufacturing. You will ensure adherence to cGMP and regulatory requirements while working closely with cross-functional teams.

The role involves review/approval of MES records and GMP documents, participation in deviations, and maintaining aseptic practices with 25% cleanroom presence.

Qualifications

  • Minimum 2 years in Quality or Manufacturing with F&E exposure.
  • GMP/Life Sciences industry experience.
  • Excellent written and verbal communication.
  • Ability to work with minimal supervision in a fast-paced environment.
  • Experience with enterprise systems (Maximo, MES, Veeva Vault) to support quality oversight.

Responsibilities

  • Provide quality oversight for F&E, IQA Warehouse areas, and Process Development Laboratories.
  • Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and regulatory requirements.
  • Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
  • Review logbooks and GMP documentation and related reports.
  • Collaborate across PQA, PD, IQA, F&E, and Manufacturing to complete tasks.

Skills

GMP experience
Communication skills
Cross-functional collaboration
cGMP knowledge
MS Office

Education

Bachelor's degree in Life Sciences

Tools

Maximo
OEFM
MES
Veeva Vault

Job description

GTT in West Greenwich, RI seeks a QA Senior Associate - PQA for on-site duties across Facilities & Engineering, Process Development, IQA, and Manufacturing. You will ensure adherence to cGMP and regulatory requirements while working closely with cross-functional teams.

The role involves review/approval of MES records and GMP documents, participation in deviations, and maintaining aseptic practices with 25% cleanroom presence.

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