Element Materials Technology

Quality Assurance Specialist

Job Locations US-MA-Acton
ID
2021-7746

Overview

ALG, proud to be a part of Element has an opportunity for a Quality Assurance Specialist to join our rapidly growing Life Sciences group.The Senior Quality Assurance Specialist conducts Quality Assurance programs for Analytical Lab Group - East and carries out measures to ensure the fulfillment of the quality objectives of Management and the Quality Policies in the most efficient and economical manner commensurate with ensuring continuing accuracy and precision of data produced. Element’s Life Sciences group supports developers and manufacturers in the antimicrobial, food and nutraceutical, medical device, and pharmaceutical and biotechnology industries. We provide personalized testing solutions and regulatory consulting support to validate the safety and efficacy of our clients’ products at every stage of development, production and market release.

 

Responsibilities

  • Helps to develop and carry out Analytical Lab Group - East GMP Quality Assurance (QA) program, which enables the laboratory to meet desired quality standards at minimum cost
  • Monitors quality assurance activities of the laboratory to determine conformance with authorized policies and procedures and with sound practices and reviews and updates Quality Assurance procedures
  • Maintains audit forms and QA records
  • Conducts laboratory audits and inspections in accordance with cGMP and ISO/IEC 17025 regulations
  • Audits final reports and certificates of analysis to ensure that they are accurate and supported by raw data

Skills / Qualifications

  • BS or BA in biology, microbiology, chemistry or related field
  • 3+ years of experience in a similar quality assurance audit role, or equivalent combination of education and experience
  • Thorough understanding of scientific studies in order to evaluate new test methods and schedule laboratory inspections
  • Able to become current and stay current with FDA current Good Manufacturing Practice Regulations (21 CFR Parts 210/211) and 21 CFR Parts 11 and 820 and ISO/IEC 17025

#LI-AL1

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 6,500 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: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

TIC Council Statement

Element is proud to be a full member of the Testing, Inspection & Certification Council (the “TIC Council”), an international association representing independent testing, inspection and certification companies. 

 

Members of the TIC Council must implement and abide by the TIC Council Compliance Code. Element has therefore issued an overarching Code of Conduct which is supported by our Compliance Programme. A copy of the Code of Conduct and more information about our Compliance Programme can be found in the Governance and Integrity section of www.element.com

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