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Good Laboratory Practices Quality Assurance Specialist

Learn more about The Clorox Company
The Clorox Company

The Clorox Company

Good Laboratory Practices Quality Assurance Specialist

Pleasanton, CA
Full Time
Paid
  • Responsibilities

    At Clorox, we champion people to be well and thrive by doing the right thing, putting people at the center, and playing to win. Led by our IGNITE strategy, we build brands that make a positive difference in people's lives around the world. And we know that success requires head, heart, AND guts - all three, every day - coming together to work simpler, faster, bolder, and more inclusively. Interested? Join us to #IgniteYourCareer!

    YOUR ROLE AT CLOROX:

    As a Scientist II in Global Stewardship, 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 $1.5 billion 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.

    IN THIS ROLE, YOU WILL:

    PROGRAM MANAGEMENT

    • As a member of 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:

    Years and Type of Experience

    REQUIREMENTS:

    • 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 and 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 management experience
    • Ability to understand and interpret GLP regulations and technical documents
    • Ability to work independently and collaboratively in a fast-paced, cross-functional team environment
    • Effectively manage multiple priorities; results-oriented; process-driven
    • High attention to detail
    • Flexible and adaptable to changing business needs and priorities
    • Strong oral and written communication skills with ability to engage and influence various audiences at multiple levels in the organization
    • Excellent planning, organizational, and time management skills with attention to detail
    • Some travel may be required (approximately 5%)

    WE SEEK OUT AND CELEBRATE DIVERSE BACKGROUNDS AND EXPERIENCES, AND WE KNOW YOU DON'T NEED A DEGREE TO SUCCEED. WE'RE LOOKING FOR FRESH PERSPECTIVES, A DESIRE TO BRING YOUR BEST, AND A NON-STOP DRIVE TO KEEP GROWING AND LEARNING.

    AT CLOROX, WE HAVE A CULTURE OF INCLUSION. WE BELIEVE OUR VALUES-BASED CULTURE CONNECTS TO OUR PURPOSE AND HELPS OUR PEOPLE BE THE BEST VERSIONS OF THEMSELVES, PROFESSIONALLY AND PERSONALLY. THIS MEANS BUILDING A WORKPLACE WHERE EVERY PERSON CAN FEEL RESPECTED, VALUED, AND FULLY ABLE TO PARTICIPATE IN OUR CLOROX COMMUNITY. LEARN MORE ABOUT OUR I&D PROGRAM & INITIATIVES HERE .

    BENEFITS WE OFFER TO HELP YOU BE WELL AND THRIVE:

    • Competitive compensation
    • Generous 401(k) program in the US and similar programs in international
    • Health benefits and programs that support both your physical and mental well-being
    • Flexible work environment, depending on your role
    • Meaningful opportunities to keep learning and growing
    • Half-day Fridays, depending on your location

    Please apply directly to our job postings and do not submit your resume to any person via text message. Clorox does not conduct text-based interviews and encourages you to be cautious of anyone posing as a Clorox recruiter via unsolicited texts during these uncertain times.

  • Industry
    Consumer Goods
  • About Us

    Clorox builds brands that make everyday life better, every day. We value our differences, and challenge each other to think and act boldly. We try new things, succeed, fail and keep learning. We work hard, have busy personal lives and are all able to make a positive impact -- at Clorox, in our communities and in the lives of millions of people who invite us into their homes and workplaces. Make your mark and help us drive growth that is profitable, sustainable and responsible.