Quality Manager

Element has an opportunity for a Quality Manager to join our rapidly growing Life Sciences Business Unit. The Quality Assurance Manager oversees quality programs and quality assurance colleagues for Element Materials Technology, Concord and carries out measures to ensure the fulfillment of the quality objectives of Management and the Quality Policies in the most efficient and economical manner commensurate with ensuring continuing accuracy and precision of data produced.Element''s Life Sciences group supports developers and manufacturers in the antimicrobial, food and nutraceutical, medical device, and pharmaceutical and biotechnology industries. We provide personalized testing solutions and regulatory consulting support to validate the safety and efficacy of our clients'' products at every stage of development, production and market release. Responsibilities Leads Quality Assurance personnel to develop and carry out cGMP and ISO/IEC 17025 Quality Assurance (QA) program, which enables the laboratory to meet desired quality standards at minimum costMonitors quality assurance activities of the laboratory to determine conformance with authorized policies and procedures and with sound practice.Assists in maintaining efficient Quality Assurance operations by advising and assisting in the installation of QA programsEvaluates/manages the performance of the Quality Assurance staff Conducts laboratory audits and inspections in accordance with GMP and ISO 17025 regulationsAudits final reports and certificate of analyses to ensure that they are accurate and supported by raw data Skills / Qualifications BS or BA in biology, microbiology, chemistry or related field or equivalent experience6 to 10 years'' minimum experience in a similar quality assurance audit role, or equivalent combination of education and experienceFamiliarity with lab operations, quality assurance and regulationsAble to become current and stay current with FDA current Good Manufacturing Practice Regulations (21 CFR Parts 210 and 211 and Quality System Regulations 21 CFR Part 820) and ISO/IEC 17025Able to understand published methodology to audit existing test methods and ensure accuracyLI-AL1 Diversity Statement At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world''s most trusted testing partner".All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

Created: 2021-11-29