Bausch Health

  • Manager QA Lab Support

    Location US-FL-Tampa
    Job ID
    11811
    Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Manages and coordinates activities and resources associated with Quality Assurance overseeing Lab activities and controls to include the approval of incoming and finished product testing data, lab OOS and non-conformance, stability, raw material, component, calibration, and lab equipment qualification.

    Responsibilities

    1. Manage Quality Assurance Department disposition of laboratory testing (incoming, finished product and stability) to evaluate all pertinent data related to release decisions for the QC Laboratory.
    2. Oversee Lab Testing Data Review and Release QC Lab results
    3. Oversee Lab related OOS investigations, Non-conformance; Deviation and CAPA program.
    4. Quality oversight of lab validation, including protocol and final report review/approval.
    5. Responsible for the GxP, ISO, and EHS procedure awareness and compliance within the respective area. 
    6. Representative for QA oversight of the QC lab at customer and regulatory audits.
    7. Oversee System Administration activities on LAB Equipment, access control, LIMS etc.
    8. Assure departmental compliance of applicable FDA, OSHA (safety), ISO, etc. regulations and support compliance awareness through tracking and communication of key metric data.
    9. Attend all regulatory requests for laboratory data, COAs, etc.

    Qualifications

    Bachelor’s Degree with a major in Chemistry, Engineering or Biological/Chemical Science.

     

    10 years in pharmaceutical or medical device FDA GxP environment and 5+ years of supervisory experience.  Thorough knowledge and understanding of data integrity

     

    Thorough knowledge of pharmaceutical manufacturing/controls and Good Laboratory Practices.

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