- Reviews all source data and associated documentation for accuracy and cGMP conformance, as well as Certificates of Analysis, client protocols, raw data files, in-house paperwork and logbooks
- Supports in the preparation and collation of training material and other relevant quality related activities
- Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made
- Assist in the investigation and review of deviation reports (NCRs) and OOS reports to assure complete and compliant source data
- Approves all investigations including but not limited to metrology, deviations, OOS and OOT, and suspect data investigations.
- Performs Quality Assurance audits on laboratory areas to ensure cGMP compliance, and performs training and mentoring junior staff members of the quality team
- Bachelor's degree in the sciences - Chemistry, Biology, Microbiology, or equivalent experience required
- A minimum of 5 years of laboratory experience in an FDA regulated laboratory environment
- Preferably experience with GMP laboratory experience in wet chemistry techniques, ICP-MS / ICP-OES, and spectrophotometric techniques, such as UV-VIS, liquid chromatography, gas chromatography, GC-MS, LC-MS, NMR and other general laboratory techniques
- Demonstrate a consistent high-level integrity, professional discipline and dedication to quality compliance and improvement.
- Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension
- Able to perform data review proficiently for the majority of the day when needed
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Senior Quality Assurance Specialist - Santa Fe Springs, United States - Element Materials Technology
Description
Senior Quality Assurance Specialist
Job Locations
US-CA-Santa Fe Springs
ID
Overview
Element has an opportunity for Senior Quality Assurance (QA) Specialist. In general, the duties of this position, like those of a Quality Assurance Specialist, are geared toward assisting Quality Assurance Management in administering the company's quality system. This is accomplished through the review of laboratory technical records, preparing and performing internal audits, negotiating compliance records, and participation in various quality improvement projects. The Sr QA Specialist. will also be asked to participate in the training of new staff. Overall, the Senior Quality Assurance Specialist position presents the employee with an opportunity to both learn the skills required to advance in the management field of Quality Assurance.
The pay range for this role is set between $33/hr.-$44/hr., but will depend on level of experience and relevant background.
Responsibilities- Responsible for ensuring the integrity of all data and documentation reported from the Laboratory - routine reports, method verifications, validations, equipment qualifications, etc.
#LI-TK1
Company OverviewElement 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.
Diversity StatementAt 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 c)
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