GLP Quality Assurance Specialist

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** Your role at Clorox:*
* As a Scientist II in Global Stewardship / Regulatory, you will be part of the Quality Assurance Unit (QAU) with responsibility for Good Laboratory Practice (GLP), working with a cross functional team to generate quality data and documentation for business critical Regulatory submissions to the US Environmental Protection Agency (EPA). This critical work is a key driver for delivering Cleaning Business objectives and enables health of the Cleaning Business.

Federal regulations require the use of Good Laboratory Practices (GLP) for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA. GLP standards require implementation of a robust quality management system to ensure the validity, integrity and reliability of data submitted for regulatory evaluation and EPA approval.

A QAU exists to assure management that facilities, personnel, practices and records are in compliance with regulations, to maintain a master schedule sheet of studies, to inspect each study at intervals to assure compliance and to report findings to Study Director, Study Sponsors and Management.

This role is focused on 40 CFR Part 160 (EPA-GLP) compliance of product chemistry studies related to testing of antimicrobial products.

This position will be located in our Pleasanton, CA office, and the individual will be expected to be in the office of 3 days a week.

** In this role, you will:*
* Program Management

+ As the QAU:

+ Collaborate within the QAU and with GLP staff to develop and implement improvements for overall test facility compliance

+ Provide input to management via quarterly updates

Auditing

+ Be responsible for the inspection of protocols, in-process testing, data/draft reports, final reports

+ Coordinate CPC annual facility self-assessment and contract labs inspections. Communicate observations and implement changes as needed

+ Identify and drive improvements and efficiencies within the auditing process

Training/Guidance

+ Lead training for GLP personnel

+ Provide guidance on GLP regulations/requirements for each GLP study as needed

+ Improve training materials and experience to better prepare users for GLP

Study-Specific Activities (excluding auditing)

+ Define studies and set timing with GLP product team members

+ Review draft protocols, deviations, amendments, and study notes and provide input and guidance on format/content

+ Generate and distribute inspection reports to Study Director & management

+ Review revised data/report to ensure all audit findings are appropriately addressed

+ Sign final report QA statement

+ Identify, develop and champion improvements to study-specific activities

Other

+ Represent Clorox during EPA inspections

+ Monitor and implement new processes to address changes in regulations or internal practices

+ Interact w/ contract laboratories on QA/GLP issues

+ Update and issue Master Schedule

+ Review and provide input on draft SOPs

+ Maintain QAU files

+ Seek to continuously find opportunities to improve GLP activities

** What we look for:*
* + Bachelor or Masters degree in Chemistry or other related Science discipline or a Quality-oriented education.

+ 2-4 years laboratory, quality or plant work experience

+ Analytical skills and knowledge

+ Good Laboratory Practice (GLP) or Good Manufacturing Process (GMP) experience

+  
** Desired:*
* + Knowledge of 40 CFR Part 160 regulations, analytical techniques (including, but not limited to, manual titration, LC and GC), familiarity with CPG product development, micro and toxicity testing is desired.

** Skills & Abilities:*
* + Strategic thinking and ability to increase the quality-consciousness of employees by your persuasiveness

+ Customer and quality focused, team spirit and integrity

+ Experience representing GLP compliance in a cross-functional team setting and project…