Job Information
Valent BioSciences Quality Analyst - Valent U.S.A. LLC in San Ramon, California
About us:
Valent U.S.A. LLC, a wholly owned subsidiary of Sumitomo Chemical Company, Limited, engages in the development, registration, sales, and marketing of integrated technological solutions for crop production and pest management that deliver value for our customers and stakeholders. A leading crop protection firm serving the agricultural and non-crop products markets in North America, Valent products help growers produce safe and abundant food and fiber crops, and horticultural professionals improve the quality of life for their customers. The corporate motto, Products That Work, From People Who Care®, describes the company's business philosophy. Valent seeks out and provides customers with innovative and effective solutions to their production challenges. Our vision is to be the best company delivering integrated solutions of biorational and traditional crop protection solutions to our customers. Valent is dedicated to creating a world that is healthier and more comfortable, and that has a sustainable abundance of quality, affordable food, helping crops to be the ultimate renewable resource.
General Description:
The purpose of this position is to establish, maintain, and develop quality assurance programs, policies, procedures and controls ensuring that Valent U.S.A and Valent BioSciences’ federally regulated products and processes conform to established EPA Good Laboratory Practices (GLP) standards and guidelines. Provides expertise and guidance in interpreting governmental regulations and agency guidelines related to GLP studies. Assists in the archival and long-term maintenance of GLP documents according to federal guidelines.
Principal Responsibilities:
Review GLP study protocols, conduct GLP in-life audits as well as detailed audits of GLP raw data and final reports of various groups (Residue, Analytical, and Environmental Fate and Metabolism), and prepare audit reports of any discrepancies and/or recommend appropriate corrective actions to study directors and management.
Establish policies and procedures to ensure GLP compliance. Stay current on interpretation of regulations through study of documents, consultation with agency personnel, and training meetings. Counsel and advise technical and regulatory personnel on EPA and OECD GLP issues.
Participate as part of the Quality Assurance Unit in the establishment of policies and procedures to ensure compliance with domestic Good Laboratory Practice (GLP) standards
Counsel Valent laboratory, field and contract personnel on current GLP policies and procedures. Collaborate with GLP study personnel and management to provide assurance that GLP studies are in compliance with EPA GLP regulations and internal SOPs.
Coordinate activities and assist with interactions during regulatory agency inspections and in conducting internal GLP training classes, as required.
Audit internal and/or external GLP facilities/laboratories as needed to review and assess processes and systems to identify procedural and systematic compliance risks and recommend practical corrective actions.
Administer the Master Schedule for VUSA and VBS.
Manage and maintain independently the Valent GLP archives. Demonstrate expertise in using the archive database and procedures by entering, retrieving, and tracking data and specimens in the internal archive and at the third-party archives both for Valent, Sumitomo, and other partners. Perform inspection of external GLP archive facilities independently as needed.
Take primary responsibility for both Valent USA and Valent Biosciences’ GLP SOP systems. Initiate and coordinate the review and revision and maintain original and superseded SOPs per GLP regulation.
Qualifications:
Typically, a BA/BS, MBA, and/or 4 – 8 years of related experience.
Registered Quality Assurance Professional (RQAP) certification desired.
Physical Demands and Work Environment (LAB Position):
The physical demands and works environment characteristics described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Demands include constant sitting, walking, standing, bending at the neck and waist, squatting, climbing, kneeling, crawling, twisting at the neck and waist, simple grasping, power grasping, and fine manipulation with hands, pushing and pulling with hands, reaching above shoulder level, and lifting and carrying up to 25 lbs., and occasional lifting and carrying of up to 50 lbs.
Work Environment includes exposure to or working in or around equipment, and machinery including a computer keyboard and mouse; uneven ground; excessive noise; extremes in temperature, humidity, or wetness; dust, gas, fumes, or chemicals; heights;. May be required to wear a respirator and other personnel protective equipment (including special visual or auditory equipment).
Frequency Definitions: Constant = Over 40% / Frequent = Up to 40% / Occasional = Up to 10%
What We Offer:
You’ll enjoy competitive compensation, consisting of base pay plus an incentive program available to all eligible full-time employees, and a comprehensive benefits package including high-quality healthcare options, 401k matching, life and disability insurance, generous time off (with time off to volunteer) and much more! Additionally, we offer several Flexible Work Arrangements to support a healthy work-life balance.
We work together to power our sustainable future. Here's what drives us: Valent U.S.A. LLC has a strong commitment to both sustainability and corporate social responsibility (CSR). In fact, being a responsible corporate citizen has been ingrained in our culture since the company’s founding. Today, it remains at the forefront of everything we do.
Valent U.S.A. LLC is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation and/or identity, national origin, citizenship, immigration status, disabilities, or protected veteran status.