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Compliance Coordinator II

Irvine, CA 92602

Posted: 04/08/2025 Employment Type: Contract Job Category: Other Job Number: 618674 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 44.07-52.38/hr **salary will be commensurate with experience 

Job Description:

The purpose of this position is to support the QA organization.  This role performs multiple, high-level administrative functions in support of the organization.
• Collect, analyze, and report on quality metrics to track performance and identify areas for improvement.
• Conduct assessments of IMPACD documents to ensure compliance with regulatory requirements and internal standards.
• Handle Health Authority Queries (HAQ) from Health Authorities (HA) efficiently and accurately.
• Undertake root cause analysis of incidents requiring corrective action; perform thorough root cause analysis to identify issues and implement corrective actions.
• Develop and manage Corrective and Preventive Actions (CAPA) and Engineering Change (EC) processes.
• Ensure that corrective measures and deviation meet acceptable reliability standards and that documentation is aligned with requirements.
• Review and verify Certificates of Analysis to ensure product quality and compliance.
• Provide guidance and training to new associates to ensure they understand and adhere to quality standards.
• Maintain and improve quality systems to ensure ongoing compliance and efficiency.
• Participate in and support internal and external audits to ensure compliance with regulatory and company standards.
• Design and analyze inspection and testing processes, mechanisms, and equipment.
• Conduct quality assurance tests and perform statistical analysis to assess the level of control and handle product quality risks.

Must Haves:

• Bachelor’s Degree in Engineering or Sciences or equivalent years of directly related experience (HS+10 yrs; Assc+6 yrs; M.S.+2 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2+ years of relevant work experience performing system configuration, database management, and/or learning management systems.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.