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Quality Investigations Supervisor

PRIMARY DUTIES AND RESPONSIBILITIES:
  • 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.
  • Will provide direction, scheduling and training of the QA investigators 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 preventative actions to improve process quality.
  • 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.
  • 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.
  • Perform review of quality related documents.
  • Other duties and responsibilities as assigned.
  • What your background should look like (minimum qualifications)

  • Bachelor s Degree in Science or related field preferred.
  • Minimum of 3-5 years experience in Quality, Operations, or related field in the healthcare industry. (Experience in FDA/DEA regulated environment a plus.)
  • Aseptic processing experience is a plus
  • Team lead or supervisory experience required.
  • MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Computer skills in word processing, spreadsheets and databases required.
  • Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills
  • Must be able to communicate technical, scientific, and regulatory information, both written and verbally.


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