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
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.