Quality Assurance Supervisor

Location: Columbia, SC
  • Must be willing to travel
  • This position will require travel to the Green Acres, FL location until June 2018 when the facility opens.
  • Travel schedule: 3 weeks blocks in Green Acres, FL and work from home for 1 week until the new facility opens.

  • Maintains current knowledge of FDA, EU, industry, and applicable state regulations in addition to customer specifications.
  • Ensure all product shipments comply with all federal, state, customer, and ImmunoTek requirements.
  • Ensure sample shipments are appropriately released, accurately labeled and shipped to testing laboratory.
  • Ensure donor center records are complete and accurate.
  • Ensure that supplies and materials meet requirements.
  • Ensure compliance with SOPs and that SOP revisions are implemented correctly. Including system process assessments to make the systems more efficient and effective.
  • Work with Center Management and Quality Assurance Unit staff to develop Corrective Actions and Preventive Actions (CAPA’s) for inspection findings; ensure CAPA’s are implemented and effective.
  • Ensure that equipment is qualified, maintained and calibrated properly. Review and verify repair documentation is complete and approve equipment for return to service.
  • Ensure that proficiency testing process is completed properly and according to required timelines, graded results are evaluated, and failing results are investigated through the Deviation Management process.
  • Verify employee training is complete and documented properly.
  • Ensure deviation investigations are handled appropriately and actions completed to facilitate closure within required timelines. Respond to QA Tracking and Trending errors, external audit findings, and internal audit findings.
  • Recommend Corrective and Preventative Action Plans (CAPA) to Operations for implementation. Collaborate with Center Management to ensure appropriate and sustainable CAPA is implemented.
  • Monitor and evaluate adequacy of Corrective and Preventative Actions, completeness of reports, assist in root cause analysis.
  • Investigate and propose additional corrective actions as required.
  • Ensure compliance with SOPs and that SOP revisions are implemented correctly.
  • Train center staff, as required, on new SOPs, SOP revisions, corrective and preventive actions.
  • Ensure document control requirements are met.
  • Supervise Quality Assurance Unit and donor center Quality Assurance activities.
  • Train other designated staff in performing the functions of the QAU position.
  • Perform other duties as assigned.

  • Undergraduate degree in one of the Allied Sciences (Chemistry, Biology, or Medical Technology) or professional equivalent, such as R.N. unless applicable experience equivalent is approved by senior management.
  • One (1) year experience in a regulated environment, donor center, laboratory, drug manufacturing, medical device, or in-vitro diagnostic industry unless applicable experience equivalent is approved by senior management.
  • Previous experience should demonstrate expertise in interpreting regulations (e.g., cGMPs, FDA, EU), SOP development, as well as an understanding of quality principles.
  • Previous work experience should demonstrate good interpersonal, written and verbal communication skills, multi-tasking ability, and the ability to work independently.
  • Computer literate
  • Must be able to travel to train staff in other centers or assist in meeting compliance requirements.
  • Must be able to work independently and work weekend hours.
April A. Estes
Senior Recruiter
720-439-2609 Direct

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