GLP Study Director (H)

GLP Study Director 1281023 (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 DirectorPay and Benefits:

• Hourly pay: $35/hr
• Worksite: Worksite: Leading consumer products company (Pleasanton, CA 94588 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 3 Month Assignment with a possibility to extend.

GLP Study DirectorResponsibilities:

• 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 DirectorQualifications:

• 5+ years working in a laboratory desired.
• At least 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.