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QA Associate

Posted: October 30, 2023
Salary:US$30.00 - US$35.00 per hour
Location:South Plainfield
Job type: Contract
Discipline:Life Sciences
Work Location:On-site

Job description

Quality Assurance Associate

Job Responsibilities:

  • Review analytical raw data to ensure conformance to specifications and ensure documentation in compliance with cGMP regulations and FDA guidelines.
  • Issue Certificate of Analysis after full review of analytical raw data.
  • Critically review and release data packages and technical reports produced by Laboratory Team to assure compliance with SOPs and FDA cGMP standards
  • Review Method Validation, Method Verification raw data of API, raw materials, finished products.
  • Ensure Standard Operating Procedures (SOPs) and all method documentation is up to date and compliant per FDA cGMP/GLP requirements
  • Collaborate with Lab Team and Client Relations to investigate, troubleshoot, and resolve out of specification (OOS) results
  • Review equipment/instrument logbooks to ensure accuracy and completeness.
  • Assure all documentation (hard copy and digital) is complete, compliant, and of adequate quality to withstand FDA audit
  • Assist QA manager in Internal Audits and inspection readiness activities of external audits.
  • Identify training needs for chemists in documentation to ensure compliance.
  • Ensure compliance with Company's policies and QMS requirements
  • Assist QA Team in upgrading/implementing new QMS, documentation, and change control solutions
  • Independently manages own day-to-day activities to support Lab objectives

As a job seeker, you face the daunting challenge of finding and landing a position that truly suits your talents and your career ambitions. At Medix, we are passionate about partnering with you to match you with the jobs and companies that are right for you. Our personalized placement services provide flexibility to accommodate your schedule and needs, as we offer contract, contract-to-hire, and direct hire opportunities. We will also provide guidance and support during the interview process-if you need anything, from resume tips to information on the company you're interviewing with, your recruiter is only a phone call away. Best of all, our placement services are 100% free to you.

As a Medix contractor, you can choose to enroll in our benefits program and enjoy:

  • Supplemental medical coverage
  • Prescription program
  • Dental coverage
  • Vision coverage
  • Term life Insurance plan

Medix - Anticipating Needs. Exceeding Expectations.

Apply now!