Overview

Element has an opportunity for Senior Quality Assurance (QA) Specialist. In general, the duties of this position are geared toward assisting Quality Assurance Management in administering the company’s quality system. This is accomplished through the review of laboratory technical records, performing internal audit performance and reporting, and participation in various quality improvement projects. The Senior (QA) Specialist. will also be asked to participate in the training of new staff. Overall, the Senior (QA) Specialist position presents the employee with an opportunity to both learn the skills required to advance in the management field of quality assurance.

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 of the vendor qualification process
• Assist in the investigation and review of deviations, change controls, CAPAs, and OOS reports to assure complete compliant source data
• 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.
• Understands testing and procedures within quality testing
• 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

• Bachelor’s degree in the sciences
• Experience in supplier management
• Experience in an FDA regulated laboratory environment
• Proficiency in Microsoft Office
• Quality experience in a relevant industry sector/relevant quality standard(s)
• Excellent written and verbal communications skills
• Ability to solve complex Quality and technical related problems
• Experience in chemistry, microbiology and virology laboratory techniques a plus
• Experience with MasterControl eQMS a plus

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Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 7,500 brilliant minds operating from 200 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.