Skip to content

Job Openings

MFG Compliance Specialist

Fremont, CA 94555

Posted: 11/12/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 615875 Is job remote?: No Country: United States

Job Description


Duties:    
  • Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations.
  • This position will support in the monitoring, reporting of deviations, change controls and improvement projects.
  • This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions.
  • Helps to Identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.

Skills:    
  • Possesses knowledge in the area of manufacturing biopharmaceuticals. Has experience in managing simple to moderate projects, and CAPA.
  • Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions.
  • Has some knowledge of change controls, deviations, project management, and audits/inspections.
  • Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.
  • Projects are cross functional and the project scope is limited.
  • The specialist should be able to independently influence peers to achieve a common goal.
  • Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)
  • Time management: Must be able to multi-task and be organized.
  • Experience in biotech, pharmaceutical manufacturing is a requirement.
  • Preferably experience being a manufacturing operator or technician.

Education:    
  • Bachelors Degree with a focus in Biopharmaceuticals. 

Experience:
  • 2 Years Experience with cGMP and biopharma





Pay Rate Range: $35-45/hr depending on 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 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.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

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

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.