Search Jobs
Compliance Coordinator II
15800 Alton Pkwy Irvine, CA 92602 US
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Irvine, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.