2 GLP Study Director Pleasanton, CA Duration:- 3 Months Jobs in Pleasanton, CA
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GLP Study Director Pleasanton, CA Duration:- 3 Months
$126k-162k (estimate)
Contractor | IT Outsourcing & Consulting
2 Weeks Ago
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APN Software Services, Inc is Hiring a GLP Study Director Pleasanton, CA Duration:- 3 Months Near Pleasanton, CA
Title:- GLP Study DirectorLocation:- Pleasanton, CA (Onsite position)Duration:- 3 MonthsGLP 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 Client
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): Include Key Responsibilities with 2-3 activities as sub bullets if needed
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
RequirementsAssociate'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
Desired5 years working in a Laboratory
Good Laboratory Practice (GLP) or Good Manufacturing Process (GMP) experience
Experience working on EPA regulated products
MinimumAbility 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 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
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 Client
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): Include Key Responsibilities with 2-3 activities as sub bullets if needed
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
RequirementsAssociate'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
Desired5 years working in a Laboratory
Good Laboratory Practice (GLP) or Good Manufacturing Process (GMP) experience
Experience working on EPA regulated products
MinimumAbility 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 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
Job Summary
JOB TYPE
Contractor
INDUSTRY
IT Outsourcing & Consulting
SALARY
$126k-162k (estimate)
POST DATE
06/12/2024
EXPIRATION DATE
07/02/2024
WEBSITE
apninc.com
HEADQUARTERS
NEWARK, CA
SIZE
25 - 50
FOUNDED
1996
TYPE
Private
CEO
ASLAM CHANDIWALLI
REVENUE
$10M - $50M
INDUSTRY
IT Outsourcing & Consulting
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