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Quality Investigations Supervisor


Quality Investigations Supervisor

Job Type: Direct-hire / Full-time
Shift:?2nd or 3rd?


Location:?Dayton, NJ


DESCRIPTION:?

The Quality Supervisor will lead a staff of Quality investigators that perform quality assurance investigation activities and functions throughout the facility. The Quality Supervisor will work alongside the Quality Manager in ensuring compliance to company procedures and regulatory requirements through direct observations and review.


PRIMARY DUTIES AND RESPONSIBILITIES:



  1. Will be responsible for review, approval and seeking compliance approval for the facility investigations written by QA/QC/Operation investigators. Ensures compliance to procedures and addresses non-compliance issues.

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

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

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

  5. Daily activities will include but not limited to: review and approval of the investigations and exception documents related to laboratories, batch processing, label and packing, environmental monitoring, training of specific procedures.

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

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

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

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

  10. Perform review of quality related documents.

  11. Other duties and responsibilities as assigned.


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. Aseptic processing experience is a plus

  4. Team lead or supervisory experience required.


MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:



  1. Computer skills in word processing, spreadsheets and databases required.

  2. Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills

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


 

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