Planet Pharma
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https://www.propharmagroup.com
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Target PR Range: 39-49/hr
*Depending on experience
Job Title: Document Coordinator for Biologics Process Validation
Department: PDM/ Technical Development/ Pivotal & Commercial Biologics Job
Responsibilities:
Knowledge & Skills Required
Education & Experience
Document Coordinator for Biologics Process Validation
Posted: 09/11/2024
2024-09-11
2024-10-12
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 614298
Is job remote?: No
Country: United States
Job Description
Target PR Range: 39-49/hr
*Depending on experience
Job Title: Document Coordinator for Biologics Process Validation
Department: PDM/ Technical Development/ Pivotal & Commercial Biologics Job
Responsibilities:
- Create, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation program
- Act as a Project Manager to track and monitor Process Validation progress and deliverables
- Coordinate Process Validation documentation: Prepare, edit, proofread, coordinate and adjudicate reviewer comments with author and subject matter experts
- Perform Data Verification of completed Process Validation studies and reports
- Create study templates to drive alignment
- Work across Quality Assurance, Process Development, MSAT, and Contract Manufacturing Organizations
Knowledge & Skills Required
- Excellent verbal and written communication skills
- Strong quality mindset
- Strong attention to detail
- Strong project management skills
- Must have understanding and application of GMP principles, concepts, and practices
- Knowledge of biochemical manufacturing process and terminology
- Knowledge and experience in process validation in highly regulated manufacturing environments
Education & Experience
- Bachelor's degree in life sciences or related field
- Minimum of four years experience in biotechnology, process validation, Quality, or a related area
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