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Quality Assurance Supervisor

What you will be doing

To lead a staff of Quality Technicians or Quality Associates that performs daily quality assurance activities. Ensures that staff performs routine tasks in a timely manner
according to established Standard Operating Procedures through direct
observation.

  • Will be responsible for daily quality operations within the department.
    Ensures compliance to procedures and addresses non-compliance issues.

  • Will provide direction, scheduling and training of the QA Technicians on new
    systems, procedures, and day to day activities.

  • Will conduct internal
    audits of processes, systems and procedures.

  • Will participate in
    cross-functional teams to identify effective corrective and preventive actions
    to improve process quality.

  • Daily activities will include but not
    limited to: batch processing, label and packing, environmental monitoring,
    training of specific procedures.

  • Will assist Quality Manager to assure
    timely closure of audit items.

  • Will initiate SOP revisions as needed
    to assure compliance, continuous improvement.

  • Will provide reports
    from QA and data to support other business functions as needed for continuous
    improvements efforts within the facility.

  • Conduct root cause analysis
    for compounding errors and processing errors generated at the facility during
    all phases of the production process.

  • Coordinate and schedule testing
    of all products for the on-going stability and on-going sterility monitoring
    programs with the appropriate contract labs (ensure product is produced and
    shipped to the appropriate lab in a timely manner).

  • Perform review of
    quality related documents.

  • Will be responsible for tracking product
    lots from the generation of batch records through the final disposition. This
    will be done through the issuance of periodic reports to management that detail
    the status of all lots in progress.

What your background should look like (minimum qualifications)

1. Bachelor s Degree in Science or related field preferred.

2. Minimum of 3-5 years experience in Quality, Operations, or related field
in the healthcare industry. (Experience in FDA/DEA regulated environment a
plus.)

3. Experience with LEAN Manufacturing, Six Sigma experience preferred.

4. Demonstrated understanding of quality assurance in a regulated
environment.

5. Knowledge of Management Inventory Systems desired.

6. Must be able to compile, analyze and present collected data in summary
form.

7. Must be able to communicate technical, scientific, and regulatory
information, both written and verbally.

8. Computer skills in word processing, spreadsheets and databases desirable.

9. Effective problem solving, supervisory and organizational skills.

10. Must be a team player and enforce policies and standard operating
procedures.



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