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JUNIOR Process Validation
6701 Kaiser Drive Fremont, CA 94555 US
Job Description
Duties:
Candidate will work with MSAT Process Validation group with the following responsibilities:
- Responsible for performing data mapping of Continued Process Verification (CPV) software.
- Assist in the development and implementation of CPV data mapping strategies.
- Collect, organize, and map process data and QC data from various sources to ensure accurate and comprehensive data sets.
- Perform CPV evaluation and generate CPV reports.
- Generate new work instruction and curriculum to implement new CPV software.
- Maintain accurate and up-to-date documentation of CPV activities and data mappings.
- Support other process validation projects (as needed) to ensure processes are validated to required standards.
- Reviews and interprets data for accuracy for completed validations/re-validations and prepares report packages by analyzing and summarizing the data to support test and protocol requirements.
- Manage all moderate troubleshooting efforts for protocol discrepancies.
Skills:
- Basic understanding of GMP (Good Manufacturing Practices) and regulatory guidelines.
- Proficiency in Microsoft Office including Word, Excel, and Visio.
- Experience with Minitab or similar statistic analysis software is preferred
- Process validation background is preferred.
- Biopharmaceutical experience with knowledge of cell culture and purification manufacturing processes is preferred.
- Excellent technical writing and verbal communication skills
- Strong analytical and problem-solving skills.
- Ability to work effectively in a team environment.
- Demonstrate ability to manage multiple activities while maintaining a high level of organization.
- Demonstrate flexibility in problem solving, providing risk-based options towards challenges for Management review and decision making.
Education:
- Required: Bachelor's Degree.
Certifications & Licenses:
- Proficiency in Microsoft Office including Word, Excel, and Visio
Pay Rate Range: $25-34/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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