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Documentation Specialist

2 months ago

Foster City, United States Net2Source Inc. Full time

Job Description: Document Coordinator for Biologics Process Validation

Location: Foster City, CA 94404

Duration: 12+ Months (Extendable)

Pay Rate: $48.00 – 53.00/hr on W2



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


Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.