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MFG Compliance Specialist
6701 Kaiser Drive Fremont, CA 94555 US
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
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.
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