QA Operations Supervisor

Title:                            QA Operations Supervisor

Department:                 Quality Assurance

Reports To:                  Sr. Director QA/QC

Pay Classification:       Exempt

Position Summary:      Assist in the establishment, documentation, implementation and administration of Quality Assurance procedures appropriate to the regulatory requirements of the Company.

Duties & Responsibilities include but are not limited to:

  • Ensure that all processes are fully compliant, auditable and meet all regulatory and Company requirements.
  • Ensure that inspections are properly performed on all incoming and outgoing material and that appropriate paperwork is properly executed.
  • Oversee the daily activities:
    • Incoming inspection, testing and disposition
    • Finished Goods sampling and inspections
    • Distribution of batch records
    • Batch record audits
    • Batch release
    • Filing
  • Understands and follows written instructions provided in company procedures and specifications and provides training for Quality Operations staff.
  • Communicate inspection failures and non-conformances and any deviations to the procedure or specifications to QA leadership.
  • Supports handling of non-conforming product or material including segregation, identification and related documentation.
  • Ensures compliance to cGMP’s and company policies/procedures.
  • Is able to communicate and interact effectively with functional groups in operations and quality personnel.
  • Responsible for direct reports performance management process.
  • Performing other related duties as assigned.

Qualifications Required:

  • BS Degree with 1 year experience; or 5 yrs. or more of QA operations experience
  • Knowledge of MS office products (Word, Excel)
  • Detail Oriented
  • Strong communication, organization and record keeping skills
  • Ability to manage multiple activities to meet business needs.

Continuous improvement driven.

For immediate consideration, please send a resume to srivera@chembio.com
Chembio is an Equal Opportunity Employer.