Location: Davis, CA
Company: Innerplant
maintains the quality management system (QMS) for a plant biotechnology company. The Quality Assurance Manager will support regulatory (FDA, global) submissions by interfacing with external consultants and contract research organizations (CROs) and providing oversight of Good Laboratory Practice (GLP) studies.
Responsibilities: Implement, maintain, and recommend improvements to the QMS system. Effectively interface between internal research and development functions and external consultants and CROs to ensure proper record keeping and product traceability. Provide quality control and assurance for GLP studies to assure management that the facilities, equipment, personnel, methods, practices,
records, and controls are in conformance with 40 CFR Part 160. Reviews final GLP studies to ensure that they are in conformance with 40 CFR Part 160. Recommends policies and procedures for laboratory practices and safety standards.
Monitors the laboratory for compliance with established policies and safety standards. Prepares the laboratory for and participates in external audits. Conducts internal facility audits as necessary and provides recommendations to management. Qualifications: Bachelor's degree required; advanced degree in Biology, Biotechnology, Chemistry, Analytical Chemistry or closely related fields preferred. Intimate knowledge of QMS systems and standards including ISO
9001. Familiarity with GLP Regulations (40 CFR Part 160) and ISO 17025.
Minimum of five years' experience in quality assurance or quality control in a laboratory environment. Experience with agricultural and biotechnology regulatory procedures. Prior experience in conducting laboratory audits. Experience at presenting scientific findings through regulatory reports or the writing of scientific papers. Demonstrated ability to work with cross functional teams while maintaining independent judgment. Job Type: Full-time Location: Davis, California Salary and Benefits The US base salary range for this position is $85,000 - $120,000. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training.
Inner Plant's comprehensive benefits program includes medical, dental, life, and vision insurance as well as a 401(k). Inner Plant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, interaction, national origin, disability status, genetics, protected veteran status, interactionual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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