Skip to content

Job Openings

CAPA Process Analyst II

San Diego, CA 92121

Posted: 01/10/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 597257 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges from $35-41/hr
 
The CAPA Process Analyst II:
  • Progresses investigations and other activities through the CAPA program.
  • Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
  • Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
  • Leads a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Code of Conduct.
Main Responsibilities
  • Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non-conformances, potential no-nconformances, CAPAs, deviations, and/or complaint investigations.Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
  • Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
  • Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
  • Provides leadership for the initiation of improvement activities associated with identified trends.
  • Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
  • Ensures effective written and verbal communications.
  • Prioritizes workload in relation to the needs of the business.
  • Supports the attainment of Hematology goals and objectives.
Prerequisite skills
  • Knowledge of the Corrective and Preventative Action process in medical devices
  • Understanding of statistics
  • Experience with medical devices which have reagents, complex electro-mechanical and optical components.
  • Bachelor of Science in a life science or engineering discipline

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 and The Planet Group of Companies are equal opportunity employers. 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.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About San Diego, CA

Ready to embark on an exciting career journey in sunny Southern California? Explore our job opportunities in the thriving city of San Diego! Known for its stunning beaches, perfect weather, and vibrant culture, San Diego offers a unique combination of career growth and quality of life. With renowned attractions like Balboa Park, the San Diego Zoo, and the USS Midway Museum, along with a diverse culinary scene and a plethora of art galleries and theaters like the La Jolla Playhouse, there's always something new to experience. Whether you're a sports enthusiast looking to cheer for the Padres at Petco Park or seeking outdoor adventures at Torrey Pines State Natural Reserve, San Diego has something for everyone. Begin your job search today and discover why this picturesque city is the perfect place to elevate your career!

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.