Element has an exciting opportunity for a Quality Assurance (QA) Specialist to join our team, located in Santa Rosa, California. The (QA) Specialist ensures the cGMP system is effectively maintained. Maintaining SOP system development and revision program under the supervision of the QA Manager Assisting in all QA operations Acting as a designee of QA Manager Performing receipt, quarantine, and release testing on Raw and Cleaning Materials per established procedures Providing assistance during cGMP audits conducted at the facility by clients and regulatory agencies Developing, review and approval of Standard Operating Procedures and all other cGMP documentation Review of executed batch records, validation, qualification, stability protocols and reports Ensuring that quality-related investigations are properly conducted and resolved Ensuring that internal audit requirements are met Approval of contract laboratories and vendors Ensuring proper documentation maintenance Analytical experience/background, preferred Bachelor's degree in chemistry or technical field cGMP training including FDA and ICH guidelines Strong oral and written communication skills Ability to write and/or type large volumes of information with excellent attention to details #LI-TK1
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
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: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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