Element Materials Technology

Quality Assurance Specialist / Pharmaceutical

Job Locations US-MI-Ann Arbor
ID
2021-7799

Overview

Element has an opportunity for a Quality Assurance Specialist to join our rapidly growing Life Sciences group. The Quality Assurance Specialist is responsible for developing, coordinating, and maintaining a GMP compliant Quality Management System throughout the laboratory. This role specifically serves as the QA specialist for sterile fill services.

 

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

  • Serves as the QA lead for sterile fill services
  • Develops, coordinates implementation, and monitors a GMP/ISO quality management system throughout the facility
  • Assists in managing the laboratory accreditation applications and renewals including DEA licensing, FDA registration, and ISO 17025 registration
  • Assists in coordination, performance, and review of internal audits of the laboratory quality program as well as coordinates, develops, reviews, and revisions Avomeen Controlled
  • Audits laboratory compliance to pertinent controlled documents
  • Assists in managing the laboratory investigation, deviation, CAPA, and Change Control systems, and ensuring laboratory adherence to these systems

Skills / Qualifications

  • Bachelor’s Degree
  • 1-5 years’ experience in QA
  • 5-7 years’ experience in QA setting (Sr. QA Spec)
  • Excellent problem-solving abilities and an attitude of learning

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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 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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