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GLP Study Director

3 months ago

Pleasanton, United States BayOne Solutions Full time

GLP Study Director

Duration: 03 Months Contract to perm with possible extension

Work Location – Pleasanton, CA.

Pay: $28/hr.- $32/hr. on W2.

Job Description:

  • GLP Lab Maintenance
  • 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 laboratory is a safe environment for all employees
  • Provide training or approvals for scientists (or others) to enter the GLP labs

Position Summary (Mission/Purpose):

  • You will lead and manage Good Laboratory Practice (GLP) studies as a GLP Study Director.
  • You 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).
  • Federal regulations require the use of GLP for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. These regulations require implementation of a robust quality management system to ensure the validity, integrity and reliability of data submitted for regulatory evaluation and EPA approval.
  • As GLP Study Director, you will have overall responsibility for the technical conduct of GLP studies. You would be the principal point of study control for activities related to compliance for studies, collaborating with the client's employees across Product Development, Microbiology, Toxicology, Analytical and Global Stewardship.
  • GLP Studies of responsibility include Characterization to support Microbiological and Toxicology testing, Physical Chemistry and Storage Stability/Corrosion testing.

Key Responsibilities (in descending order of importance):

  • 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 incudes (but 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

Requirements:

  • 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
  • At least 1 year experience working in a laboratory with product formulation and/or analytical lab experience.