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Batch Record Reviewer II

Fremont, CA 94555

Posted: 08/23/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 613966 Is job remote?: No Country: United States

Job Description


Duties:
  • Works independently to provide quality assurance oversight in areas responsible for adhering to current Good Manufacturing Practices (cGMPs), including Quality Control Systems.
  • Demonstrates a high level of independent judgment and discretion in the timely identification, investigation, and resolution of events impacting the quality of products and processes.
  • Ensures adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements.
  • Makes difficult decisions with little time for deliberation, with potential direct impact on active manufacturing operations, the release of equipment, systems, or areas.
  • Provides quality oversight to the change management system for complex Minor and/or Major classified Change Controls, including plan creation oversight and ensuring adherence to local SOPs and regulatory compliance.
  • Performs independent technical review of documentation during and post-execution of cGMP activities, ensuring all specifications are met and applicable requirements are completed and acceptable.
  • Ensures all issues/documentation associated with each process in the assigned area have been resolved and approved prior to release to the next step, in compliance with cGMPs, SOPs, and current manufacturing regulations and site procedures.
  • Analyzes and reports findings to appropriate departments.

Skills:
  • Some Team Lead and/or Supervisory experience.
  • Attention to detail, good organizational and interpersonal skills, and problem-solving skills.
  • Ability to prioritize and work under pressure.
  • Ability to work effectively and respond quickly in a fast-paced environment.
  • Demonstrated proficiency in MS Office (MS Word and Excel) and associated computer programs.
  • Knowledge of SAP.
  • Technical knowledge of manufacturing systems, methods, and procedures.
  • Excellent written and verbal communication skills.
  • Awareness and understanding of manufacturing processes.

Education:
  • Bachelor’s degree in Life Sciences or Engineering





Pay Rate Range: $25-35/hr. Salary will be commensurate with experience 

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.

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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

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.