Job Description

Element has a current opening for a Senior Quality Specialist to join our growing team in Concord, CA). The Senior Quality Specialist’s main duties are to ensure services are compliant to the Quality Manual, client requirements and regulatory requirements as applicable such as; ISO 17025:2017, USP, CGMP, FDA and ICH guidelines at Element Concord.The Senior Quality Specialist aims to ensure that the service that is provided is fit for its purpose and meets customer expectations. The main responsibility is to ensure compliance with customer requirements and GMP regulations, as well as monitors the performance of the quality management system. Where appropriate, advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality.

Site Status: 100% On-Site

Pay Range: $85k-$95k DOE

Responsibilities

• Responsible for ensuring the integrity of all data and documentation reported from the laboratory – routine reports, method verifications, validations, equipment qualifications, etc.
• Reviews all source data and associated documentation for accuracy and CGMP conformance.
• Supports in the preparation and collation of training material and other relevant quality related activities.
• Ensure compliance with the vendor qualification process.
• Assist in the investigations. Review and approve deviations, change controls, CAPAs, and OOS reports to assure complete compliant source data.
• Manages proficiency testing program for maintenance of ISO 17025 accreditation.
• Perform internal audits and assist with client audits.
• Supporting the team to ensure calibrations, facilities / equipment qualifications and verifications, and materials receipt are being managed and are up to date.
• Verify laboratory testing is conducted in accordance with SOPs as well as compendial (USP/NF, EU) and ISO 17025:2017 regulations.
• Other duties as required and appropriate to support the quality function.

Skills / Qualifications

• A B.S. in science is desired with typically 6-8 years of pharmaceutical/biotechnology/GMP industry experience. Work is highly independent. Handles complex matters and problems autonomously, both routine and non-routine in nature.
• Confirms site regulatory quality standards adhere to Business Unit requirements. Advanced knowledge of industry and governmental quality regulations. Understands how to interpret whether procedures are followed correctly. Regularly runs root cause investigations and trends RCA data.
• Excellent time management and prioritization, strong interpersonal skills, attention to detail, plans tasks to meet deadlines, good critical thinking skills, and role models Element Values (Integrity, Care, and Progress).

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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.

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: 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)

“If you need an accommodation filling out an application, or applying to a job, please email Recruitment@element.com”