Quality Assurance Manager

Immunotek Port Orange, FL
ESSENTIAL JOB FUNCTIONS:

* 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.

* c. 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.

QUALIFICATION REQUIREMENTS:

* 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.

PHYSICAL REQUIREMENTS:

* Ability to travel via automobile or airplane.

* Ability to lift up to fifty (50) pounds.

* Ability to stand for long hours (up to 4 hours at a time) and withstand cold environment.

WORK ENVIRONMENT:

The usual work environment is in all areas of an operating plasma center and requires reasonable level of mobility and adaptability. The employee may be exposed to blood borne pathogens or freezing temperatures for short periods of time.

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