Overview

LGC, Biosearch Technologies is looking for a highly analytical and experienced quality assurance professional to join its team in Dexter, MI, as Quality Assurance Engineer. The Quality Assurance Engineer (QAE) ensures that LGC Dexter quality management system conforms to the ISO 9001:2015 standard; and that processes, procedures, and practices of product realization remain current and compliant with the Dexter QMS.

Key responsibilities and accountabilities:

  • In partnership with process participants, process owners, and stakeholders, implements, maintains, and improves procedures for the quality management processes under his/her area of responsibility
  • Assist in the development, documentation and deployment of quality system documents and processes throughout the organization
  • Works and communicates effectively across departments to implement QMS improvements and to maintain its effectiveness
  • Program coordination for one or more of the following QMS processes: the corrective action program, the internal quality audit program, supplier qualification, calibration and preventive maintenance
  • Review batch records for conformity and materials released/rejected as appropriate
  • Assist in the determination and delivery of quality system training requirements
  • Assist with the maintenance, execution and improvement of non-conformance investigations, equipment qualification, supplier qualification, customer complaints, process deviations and training records
  • Generate and review production deviations, compliant investigations, and non-conformance reports for non-conforming materials
  • Review material and product specifications and the acceptance criteria for equipment qualifications and process validations
  • Other duties as assigned by management

Qualifications:

  • Bachelor’s degree in the life sciences or a related natural sciences or engineering discipline
  • A minimum of 5 years’ work experience in a quality role within a biotechnology, medical device, or pharmaceutical company
  • Knowledge and understanding of ISO 9001:2015 quality system standards required
  • Ability to develop and deliver communications to provide timely information for action
  • Strong communication and PC skills (Proficiency in Microsoft Office products, especially Word, Excel, PowerPoint and familiarity databases) required
  • Productive in a team environment and a strong team contributor
  • Aptitude to work in a complex and rapidly growing company
  • Results-oriented, ensuring targets are met on time and on budget
  • Demonstrated good professional judgement and reliability
  • Exceptional organizational skills
  • Must be highly accurate and detail-oriented
  • Excellent oral and written communication skills (must follow good documentation practices GDP)
  • Proven experience in developing and executing continual improvement plans
  • Ability to build strong relationships on a cross-functional basis and on all levels within the business
  • Strong customer focus to meet and exceed clients’ requirements
  • High levels of personal integrity and professionalism, ability to gain trust of all colleagues and clients
  • Knowledge of Lean Manufacturing and continual improvement skills such as Six Sigma, Kaizen and 6S is highly desirable
  • The job holder will be able to demonstrate the following behaviours in line with LGC’s values: Passion, Curiosity, Integrity, Brilliance and Respect

Certificates, Licenses and Registrations:

None required. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certifications in quality management desirable.

Tracking

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