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GLP Study Director

3 months ago

Pleasanton, United States Avispa Technology Full time
Job DescriptionJob Description

GLP Study Director 1326812 (H)

A leading consumer products company is seeking a GLP Study Director. The successful candidate will lead and manage Good Laboratory Practice (GLP) studies and will work directly with cross-functional teams to generate quality data and documentation for business-critical regulatory submissions to the US Environmental Protection Agency (EPA). The ideal candidate has 5+ years working in a Laboratory. The company offers a great work environment

GLP Study Director Pay and Benefits:

  • Hourly pay: $30/hr
  • Worksite: Leading consumer products company (Pleasanton, CA 94588 - Onsite)
  • W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
  • 40 hours/week, 4 Month Assignment with a possibility to extend.

GLP Study Director Responsibilities:

  • Maintain lab documentation following Standard Operating Procedures (SOP’s) to ensure GLP compliance.
  • Maintain and calibrate lab equipment at required intervals to ensure GLP compliance.
  • Ensure laboratory supplies are available and the laboratory is a safe environment for all employees.
  • Provide training or approvals for scientists (or others) to enter the GLP labs.
  • Leads all aspects of studies to ensure data accuracy and report quality:
    • Develop study protocols that meet technical, project and regulatory objectives.
    • Ensure that all GLP regulations are communicated to study participants and are strictly observed.
    • Work independently and collaboratively with the GLP Team to execute GLP studies, design experiments and safely complete assigned tasks in a timely manner.
    • Collaboratively work with the GLP Team to maintain well-organized supporting data files suitable for internal and external auditing.
    • Complete final reports and archive studies per GLP guidelines.
  • Ensures product availability, quality, sample transfers and tracking:
    • Prepare batches with appropriate documentation and tracking for GLP studies.
    • Conduct testing on batches to ensure quality and generate accurate GLP data for EPA submissions. Testing includes (but is not limited to) pH, titrations, density, physical characteristics, etc.
    • Review analytical data and prepare final study reports, taking responsibility for accuracy and compliance.
    • Prepare and coordinate testing and transfer requirements with other functions.

GLP Study Director Qualifications:

  • 5+ years working in a laboratory desired.
  • 1+ year experience working in a laboratory with product formulation and/or analytical lab experience.
  • Associate’s or Bachelor's degree in Chemistry or other related Science discipline, or greater than 2 years of college courses in chemistry or other related science discipline.
  • Good Laboratory Practice (GLP) or Good Manufacturing Process (GMP) experience desired.
  • Experience working on EPA regulated products desired.
  • Ability to act as Project Manager of GLP Studies.
  • Excellent written, oral communication.
  • High attention to detail.
  • Excellent organizational, prioritization and decision-making skills.
  • Ability to work independently and as part of a team.
  • Push for results with a desire to learn.
  • Computer skills including Word and Excel.
  • Self-motivation, adaptability and multi-tasking skills.
  • Ability to follow SOP’s and accurate record-keeping skills.