Onsite GMP QA Senior Associate (12-hr Rotating Shift)

Aequor

West Greenwich (RI)

On-site

USD 39,000 - 55,000

Full time

16 hours ago
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Job summary

Aequor in West Greenwich, RI seeks a Quality Assurance Senior Associate with GMP, Quality/Manufacturing and Documentation experience. This onsite contract role requires working on a rotating 12-hour shift, supporting manufacturing operations and real-time quality decisions with PQA on the floor.

The ideal candidate has cGMP knowledge, strong communication, and proficiency with Microsoft Office. You will review GMP documentation, batch records, and deviations, ensure data integrity, and escalate

Qualifications

  • GMP experience is a must.
  • Knowledge of data integrity and good documentation practices.
  • Excellent written and verbal communication skills.
  • Bachelor’s degree and 2 years of Quality/Manufacturing work experience.
  • Experience in a cGMP environment.
  • Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).

Responsibilities

  • Provide Quality oversight for Manufacturing operations to ensure products are manufactured, tested, stored, and distributed according to applicable regulations.
  • Review and approve cGMP processes, procedures, documents and records; review logbooks, batch records, attachments, work orders, and other GMP documentation.
  • Ensure deviations from established procedures are documented per procedures.
  • Ensure production records and testing results are complete, accurate, and documented per written procedures and cGMP requirements.
  • Alert management of quality, compliance, supply and safety risks.
  • Be on the floor in clean room space for majority of shift; gowning in and out of frocks and coveralls.

Skills

GMP experience
Team collaboration
Communication skills
Data integrity knowledge
cGMP knowledge
Ambiguity navigation

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Aequor in West Greenwich, RI seeks a Quality Assurance Senior Associate with GMP, Quality/Manufacturing and Documentation experience. This onsite contract role requires working on a rotating 12-hour shift, supporting manufacturing operations and real-time quality decisions with PQA on the floor.

The ideal candidate has cGMP knowledge, strong communication, and proficiency with Microsoft Office. You will review GMP documentation, batch records, and deviations, ensure data integrity, and escalate

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