Element has an opportunity for Senior QA Specialist. In general, the duties of this position, like those of a Sr QA Specialist, 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 Sr QA Specialist. will also be asked to participate in the training of new staff.   Overall, the Senior Quality Assurance Specialist position presents the employee with an opportunity to both learn the skills required to advance in the management field of quality assurance.

• 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
• Reviews all source data for conformance to applicable specifications
• Supports in the preparation and collation of training material and other relevant quality related activities
• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made
• Authorized to accept or reject data based on compliance
• Ensure compliance of the vendor qualification process
• Assist with the implementation of the eQMS and keeping data up to date
• Assist in the investigation and review of deviation reports (NCRs) and OOS reports to assure complete compliant source data
• Initiate and close Change Control reports to assure complete compliant source data.
• Approves all investigations including but not limited to metrology, deviations, OOS and OOT, and suspect data investigations.
• Supporting the team to ensure calibrations, facilities / equipment qualifications and verifications, and materials receipt are being managed and are up to date.
• Interacts closely with Quality Management and all team members to identify and aid in the implementation of quality improvements
• Understands testing and procedures within Quality testing
• Performs work in accordance with general and specific safety precautions
• Interacts routinely with technical departments
• Works on multiple projects in a concurrent manner on a routine basis
• Performs Quality Assurance audits on laboratory areas to ensure cGMP compliance
• Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications (e.g., LIMS, OpenLab, MassHunter, ChemStation, Chromeleon)
• Performs training and mentoring junior staff members of the quality team
• Participate in quality, cGMP, safety, method and technique training as appropriate
• Responsible for verifying all laboratory testing was conducted in accordance with SOP’s as well as cGMP’s and GLP’s
• Participate in the SOP revision process
• Other duties as required and appropriate to support the quality function

• Bachelor’s degree in the sciences, Chemistry, preferable
• At minimum 5 years of laboratory experience in an FDA regulated laboratory environment
• Preferably experience with GMP laboratory experience in wet chemistry techniques, ICP-MS / ICP-OES, and spectrophotometric techniques, such as UV-VIS, liquid chromatography, gas chromatography, GC-MS, LC-MS, NMR and other general laboratory techniques
• 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
• Demonstrate a consistent high-level integrity, professional discipline and dedication to quality compliance and improvement.
• Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension
• Maintain a professional demeanor and adapt well in high stress environments.
• Communicate regularly and effectively with all levels of the organization
• Excellent attention to detail
• Highly organized
• Able to perform data review proficiently for the majority of the day when needed
• Timely response to updates on quality critical activities
• Able to work later in the evening or overtime when needed
• Good interpersonal skills that foster open upward and downward communication built on mutual respect

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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.

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.