Quality Assurance Supervisor

7 days ago

California, United States BioPhase Full time
Job Title: Quality Assurance Supervisor

BioPhase Solutions is seeking a highly skilled Quality Assurance Supervisor to join our team in Orange County, California.

Job Summary:

The Quality Assurance Supervisor will be responsible for ensuring the Quality Assurance staff and manufacturing processes are compliant with FDA Regulations and company policies.

Key Responsibilities:

  • Provide leadership and training to Quality Assurance Inspectors, including performance reviews, professional development, and setting objectives.
  • Develop a fully cross-functional QA team.
  • Responsible for line clearances, Critical Control points, and Quality assurance parameters during the manufacturing process.
  • Ensure Good Documentation Practices are closely followed by staff, resulting in complete and correct forms, reports, and Batch Records.
  • Oversee the identity testing process, ensuring staff has proper workflow and coverage throughout the operation.
  • Assist Quality Management in the preparation of periodic management reviews and ensure appropriate follow-up on all recommended corrective action(s).
  • Support a safe, clean, and secure working environment by supporting procedures, rules, and regulations; support plant safety committees that evaluate plant machinery, equipment, and working conditions.
  • Work closely with Operations and Operations staff, making recommendations to improve and better sustain manufacturing.
  • Support the Material Review Board and drive staff to report and close Non-Conformance Reports in the Quality Management System.
  • Implement lean manufacturing initiatives that focus on satisfying corporate goals in concert with meeting customer requirements with a sense of urgency.
  • Contribute in a team effort by performing according to the guidelines outlined in Code of Conduct, cGDP, cGMP, Lean principles, and other policies; support the directives and decisions of higher-level management and perform other duties as assigned.
  • Assist with quality and safety audits of facilities to ensure cGMP and cGMP standards are maintained and project integrity is preserved.
  • Work closely with management to resolve quality, production, and efficiency problems.
  • Act as liaison for customers with various company departments regarding quality issues as needed.
  • Assist with FDA inspections; may represent department as core or consultant member on an appointment project team.

Requirements:

  • Experience in Quality Management or Supervisor Role in a Manufacturing environment is required.
  • Bachelor's degree in food science, Manufacturing, or other related field.
  • 5+ years related experience and/or training; or equivalent combination of education and experience.
  • Formal Training in FDA Regulations or ASQ preferred.
  • Bilingual (Spanish) preferred.
  • Experience in Network-based systems, Quality Management Systems Software (QMS) & QAD preferred.
  • Ensure timely review and completion of activities to meet compliance and business targets.
  • Detail-oriented, excellent verbal and written communication skills; ability to read documents, such as standard operating procedures.

Please send resumes to BioPhase Solutions for additional job opportunities.

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