Quality Assurance Specialist- 221265

3 weeks ago


Toms River, United States Medix Full time

Summary:

The Quality Assurance Specialist will be a member of the Diagnostic Services Unit, responsible for overseeing all lab investigations, deviation reports, and change controls across a variety of different departments to ensure compliance with cGMP and company procedures.


Key Responsibilities:

  • Evaluate investigations, Change Control Requests, Standard Operating Procedures, and Analytical Methods.
  • Demonstrate the ability to make quality decisions based on cGMP, regulatory compliance, and site SOPs/documentation.
  • Conduct gap analysis of all quality-related procedures to ensure completeness.
  • Collaborate with other departments and customers to address feedback on Investigations and Deviations.
  • Work with departments to ensure timely revisions and approvals of investigations.
  • Assist in document retrieval during audits.
  • Provide training to ensure proficient use of the Trackwise system.
  • Maintain and report on quality metrics and trends in investigations.
  • Review documents to ensure compliance with company standards for formatting, review, approvals, and implementation.
  • Lead process improvement initiatives and projects within the company.



Qualifications:

  • Bachelor's degree in Chemistry or Biology required.
  • Preferably at least 3 to 4 years of relevant experience in the pharmaceutical industry, with a focus on writing laboratory investigations and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.



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