Document Coordinator for Biologics Process Validation

2 weeks ago


Foster City, United States Vakulatech Full time
Job DescriptionJob DescriptionJob Description: Document Coordinator for Biologics Process Validation
Job Location: Foster City, California
Job Duration: 12 months

Payrate: 40-45/hr on W2
Visa Status: No H1bs Other are fine

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

  • Foster City, United States Fladger Associates Full time

    Responsibilities:Excellent employment opportunity for a Document Coordinator for Biologics Process Validation in the Foster City, CA area.Department: PDM/ Technical Development/ Pivotal & Commercial BiologicsCreate, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation programAct as a Project Manager to...


  • Foster City, United States Fladger Associates Full time

    Responsibilities:Excellent employment opportunity for a Document Coordinator for Biologics Process Validation in the Foster City, CA area.Department: PDM/ Technical Development/ Pivotal & Commercial BiologicsCreate, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation programAct as a Project Manager to...


  • Foster City, United States Fladger Associates Full time

    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...


  • Foster City, United States Fladger Associates Full time

    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...


  • Foster City, United States Unicon Pharma Inc Full time

    Join our team as a Document Coordinator. If you have a strong background in biotechnology, process validation, or quality assurance, we want to hear from you!Key Responsibilities:Develop and implement procedures and best practices for Biologics Process Validation.Act as a Project Manager, tracking and monitoring Process Validation deliverables.Coordinate and...


  • Foster City, United States Unicon Pharma Inc Full time

    Join our team as a Document Coordinator. If you have a strong background in biotechnology, process validation, or quality assurance, we want to hear from you!Key Responsibilities:Develop and implement procedures and best practices for Biologics Process Validation.Act as a Project Manager, tracking and monitoring Process Validation deliverables.Coordinate and...


  • Foster City, United States Infotree Global Solutions Full time

    No Software QA/Automation please!!No H1B and/or C2C please!!One of our leading Pharmaceutical client is looking for a Quality Assurance Specialist (Biologics Document), who will be responsible for tracking and monitoring Process Validation progress and deliverables. Also Coordinate Process Validation documentation.Job Title: Quality Assurance Specialist...


  • Foster City, United States Infotree Global Solutions Full time

    No Software QA/Automation please!!No H1B and/or C2C please!!One of our leading Pharmaceutical client is looking for a Quality Assurance Specialist (Biologics Document), who will be responsible for tracking and monitoring Process Validation progress and deliverables. Also Coordinate Process Validation documentation.Job Title: Quality Assurance Specialist...

  • Document Coordinator

    2 weeks ago


    Foster City, United States ATR International Full time

    Job Title: Document Coordinator -Process ValidationType: Contract - 12 MonthsPay: $44.00-$50.00/hrLocation: 333 Lakeside Drive, Foster City, CAWe are seeking a Document Coordinator for Biologics Process Validation for a very important client. Job Responsibilities:• Create, revise, and implement procedures, best practices, and business processes for the...

  • Document Coordinator

    2 weeks ago


    Foster City, United States ACL Digital Full time

    Title: Document CoordinatorLocation: Foster City, CA Duration: 12 months 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...

  • Document Coordinator

    2 weeks ago


    Foster City, United States ACL Digital Full time

    Title: Document CoordinatorLocation: Foster City, CA Duration: 12 months 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...


  • Foster City, United States Net2Source Inc. Full time

    Job Description: Document Coordinator for Biologics Process ValidationLocation: Foster City, CA 94404Duration: 12+ Months (Extendable) Pay Rate: $48.00 – 53.00/hr on W2Job Responsibilities:• Create, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation program• Act as a Project Manager to track...


  • Foster City, United States Net2Source Inc. Full time

    Job Description: Document Coordinator for Biologics Process ValidationLocation: Foster City, CA 94404Duration: 12+ Months (Extendable) Pay Rate: $48.00 – 53.00/hr on W2Job Responsibilities:• Create, revise, and implement procedures, best practices, and business processes for the Biologics Process Validation program• Act as a Project Manager to track...


  • Foster City, United States TekWissen ® Full time

    Position: QA Documentation Specialist III Location: Foster City, CA 94404 Duration: 12 Months Job Type: Contract Work Type: Hybrid (3 days onsite)Pay Rate: $40/hr-$48/hrOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biot ech clients who...


  • Foster City, United States TekWissen ® Full time

    Position: QA Documentation Specialist III Location: Foster City, CA 94404 Duration: 12 Months Job Type: Contract Work Type: Hybrid (3 days onsite)Pay Rate: $40/hr-$48/hrOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biot ech clients who...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Senior Biologics Engineer IILocation: United States - California - Foster CityEmployment Type: Full timeJob OverviewAt Gilead, we are dedicated to enhancing global health. With over 35 years of experience, we have confronted significant diseases including HIV, viral hepatitis, COVID-19, and cancer. Our commitment to developing effective therapies is...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Senior Biologics Engineer IILocation: United States - California - Foster CityEmployment Type: Full timeJob OverviewAt Gilead, we are dedicated to creating a healthier world for everyone. For over 35 years, we have addressed critical health issues such as HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of developing therapies that enhance...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Job SummaryGilead Sciences, Inc. is seeking a highly experienced and skilled Executive Director to lead our Analytical Development team. As a key member of our Biologics Technical Development Leadership Team, you will be responsible for spearheading the analytical development of biologics programs from the Pivotal phase to commercialization.Key...

  • Research Scientist

    1 week ago


    Foster City, California, United States Gilead Sciences Full time

    About the RoleGilead Sciences is seeking a highly motivated and talented Research Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our team utilizes cutting-edge technologies and innovative methodologies to advance medicines into the clinic.Key ResponsibilitiesDesign, develop, and execute bioassay methods to mimic the mechanism of...


  • Oklahoma City, United States DERMATOLOGY EMPLOYMENT, LLC Full time

    Job DescriptionJob DescriptionSSM Health Dermatology is looking for an awesome Biologics Coordinator to join our growing team!Dermatology Employment, LLC is a rapidly growing SSM Health affiliated clinic. Our clinics offer care to patients with diseases of the hair, skin and nails. Our clinics offer a wide range of services including on-site MOHS skin cancer...