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Form of workElement Concord has a current opening for a Quality Assurance (QA) Associate. The (QA) Associate main duties are to ensure services are compliant to the Quality Manual, client requirements, and regulatory requirements (ISO 17025:2017, USP, EU, GMP, FDA, and ICH guidelines) as applicable at Element Concord.The (QA) Associate 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.The (QA) Associate helps monitor 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.
Responsibilities- Comply with and enforce data integrity requirements (21 CFR Part 11, 210, and 211)
- Maintain QA files and training matrixes
- Review Certificates of Analysis, raw data files, in-house paperwork, and logbooks
- Scan data and file records
- Submit data and Certificates to clients
- Document management and archival
- Initiate and participate in quality event investigations using MasterControl eQMS
- Support client audits
- Other duties as assigned
- A B.S. in science is desired or 1-3 years of pharmaceutical/biotechnology industry experience or in a GMP environment. Experience in a GMP microbiology lab is highly desirable
- Excellent organizational skills, good written and verbal communication skills in English, strong computer skills and customer service. Ability to work as a team member
- Ability to type, read from a PC monitor. Able to perform repetitive movements such as typing
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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.
Employment Type: OTHER
