Quality Assurance Specialist

2 days ago


California, United States CLA (CliftonLarsonAllen) Full time
Job Title: Quality Assurance Specialist

CliftonLarsonAllen (CLA) Search is seeking a Quality Assurance Specialist to join their team. The ideal candidate will have experience in commissioning, qualification, and validation within an FDA-regulated industry.

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring that pharmaceutical manufacturing systems, facilities, and equipment meet design specifications and regulatory standards. This includes developing and executing commissioning, qualification, and validation protocols to ensure compliance with Good Manufacturing Practices (GMP).

Key Responsibilities:
  • Develop and execute commissioning protocols for new and existing equipment and systems, including Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and packaging equipment, utilities, and facilities.
  • Conduct process, cleaning, and computer systems validation to ensure consistent and reproducible results.
  • Prepare and maintain comprehensive documentation, including validation plans, protocols, reports, and traceability matrices.
  • Ensure all activities comply with regulatory requirements, including FDA, EMA, and other relevant guidelines.
  • Participate in risk assessments and develop mitigation strategies to address potential validation issues.
  • Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.
  • Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Minimum of 3 years of experience in commissioning, qualification, and validation within an FDA-regulated industry.
  • Experience in facilities and equipment startup, walk-downs and troubleshooting, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation, execution, etc.
  • Strong understanding of GMP, FDA regulations, and industry standards.
  • Excellent problem-solving, analytical, and technical writing skills.
  • Proficiency in using validation software and tools.
  • Relevant certifications (e.g., ASQ Certified Quality Engineer) are a plus.


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