Element Materials Technology

Senior Quality Assurance Specialist

Job Locations US-MA-Acton


Analytical Lab Corp proud to be part of Element Materials Technology is hiring a SeniorQuality Assurance Specialist. 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.



  • Helps to develop and carry out Analytical Lab Group - East GLP 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 practice
  • Makes appropriate recommendations for correction and improvement as may be necessary.
  • Reviews and updates Quality Assurance procedures
  • Maintains audit forms and QA records
  • Assists in maintaining efficient Quality Assurance operations by advising and assisting in the installation of QA programs
  • 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
  • Participates in external regulatory audits and inspections
  • Maintains effective relationships with other staff and other departments to deliver high quality service to the organization
  • Maintains communication with Study Directors and Management on a study by study basis
  • Maintains communication with Management on department QA practices and deficiencies
  • Discusses with supervisor the needs for expansion of QA auditing staff and practices
  • Seeks out and evaluates new ideas and current developments in the field of quality assurance and recommends means for their application wherever advisable
  • Reviews new technology, methods, and equipment and advises Management as to such use, with respect to quality assurance aspects

Skills / Qualifications

  • BS or BA in biology, microbiology, chemistry or related field
  • 6 to 10 years’ minimum experience in a similar quality assurance audit role, or equivalent combination of education and experience
  • Familiarity with lab operations, quality assurance and regulations.
  • 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
  • Able to understand published methodology to audit existing test methods and ensure accuracy.Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance
  • Able to plan, prioritize, coordinate, and manage own work in a fast-paced environment. Able to work unsupervised, make moderate level decisions independently, and solve problems effectively and creatively
  • Knowledge of the general principles of classical microbiology
  • Knowledge of laboratory techniques, equipment apparatus and terminology
  • Ability to make complex mathematical computations, use statistical techniques in the treatment of data, and interpret and apply findings
  • Able to display high levels of customer service, responding promptly and thoroughly to the inquiries and needs of individuals both internal and external to the organization.
  • Able to develop and give oral presentations to small groups of individuals inside and outside the organization
  • Understand and maintain confidential nature of customer, organization and employee information
  • Show professional knowledge, proficiency and initiative in achieving goals and meeting standards
  • Excellent verbal & written communication skills


Company Overview

We are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.


We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.


Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.


Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.


We have four values that we strive to live by every single day.

  • Safety - We keep our colleagues and visitors safe
  • Integrity - We act honestly and fairly to do the right thing
  • Excellence - We set new standards of excellence in everything we do
  • Partnership - We work together for the benefit of our customers

When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY.  We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.

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.


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