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Compliance Specialist

Company: BEPC Inc. - Business Excellence Professional Consu
Location: Vacaville
Posted on: May 9, 2022

Job Description:

BEPC has an open position for a Compliance Specialist in Vacaville, CA!!Contract W2 Period: 1 Year contract with possibilities for extensionsPay & Benefits: $67/hr. + Medical, Dental, Vision and Life Insurance
Responsible for providing Front Line Engineering compliance oversight in a cGMP (current Good Manufacturing Practices) environment; maintaining areas in high state of inspection preparedness and utilizing business systems for process management. Maintain records to comply with regulatory requirements utilizing (cGMP) and Standard Operating Procedures (SOP). Support the Vacaville Manufacturing Facility by overseeing Quality System records and providing consultative subject matter expertise as a compliance expert within Facilities and Engineering.
Quality Systems

  • Serve as an example and advocate of engrained quality
  • Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and Genentech standards by applying advanced theory, technical principles and expert judgment.
  • Troubleshoot and facilitate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership.
  • Review controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product and approve changes as appropriate
  • Lead or participate in discrepancy investigations and Root Cause Analysis (RCA) as well as interact with interdepartmental contacts ensuring discrepancy identification, definition, assessment, and resolution
  • Act as an Unplanned Event Owner Lead:
  • Issue, assess as needed and follow up on assessments
  • Performing recurring unplanned event assessment
  • Summarizing the unplanned event
  • Initiate/Own remediation actions as needed.
  • Perform track and trend on discrepancies within Facilities and Engineering
  • Provide input into the design and presentation of departmental performance metrics
  • Generate, track and trend departmental performance metrics
  • Represent F&E as a planned event owner and responsible for CAPA actions, as required
  • Perform any other tasks as requested by management to support Facilities and Engineering
  • Provide a regular presence on the floor to ensure Facilities and Engineering personnel are operating within the confines of the local procedures and regulatory requirements
  • Act as a Facilities and Engineering technical subject matter expert (SME) supporting cause analysis and remediation planning
  • Exhibit detail-oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
  • Escalate process issues as necessary to ensure resolution of issue
  • Comply with cGMP, SOP and manufacturing documentation.
  • Train Facilities & Engineering team members and contribute to the improvement of compliance related training material and practices
  • Troubleshoot process equipment and systems or lead troubleshooting efforts to resolve complex process issues
  • Communicate effectively and professionally work in a team environment. Serve as department representative on cross-functional teams.
  • Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools. Identify, design and implement process and system improvements.
  • Be able to act as SME to regulatory agenciesEDUCATION:
    • BS/BA degree (preferably in Life Science) and at least five years experience in the pharmaceutical, biopharmaceutical industry, working in a cGMP manufacturing environment, or an equivalent combination of education and experience.
      Experience (may vary depending on site size/scope)
      • Sound knowledge of cGMP and equivalent regulations (such as EMA, FDA).
      • Proficient as a DMS Owner.
      • Familiarity with CAPA, Change Control and Tracking Actions.
      • Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
      • Ability to lead cross functional teams to meet document management requirements.
      • Strong organizational and project coordination skills.
        Knowledge/Skills/Competencies
        • Strong oral and written communication skills.
        • Full understanding of computer-based systems
        • Ability to make sound decisions with minimal supervision.
        • Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
        • Ability to read and understand engineering documents (such as P&ID, AFR, Visio)
        • Experience in creation and revision of Standard Operating Procedures and Manufacturing Formula is desirable.

Keywords: BEPC Inc. - Business Excellence Professional Consu, Vacaville , Compliance Specialist, Other , Vacaville, California

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