Quality Assurance Specialist
6 days ago
Microbac Laboratories, Inc. is a leading commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries.
We are seeking a result-focused, dynamic Quality Assurance Specialist who is energized by leading others to solve operational and client services challenges. This position will be housed in our Dayville, CT location and offers competitive pay, full benefits, and a wonderful opportunity to grow with our company.
Key Responsibilities:- Ensure effective and current quality systems are in place and adhered to by all staff, resulting in the output of data that is of the highest quality, accurate and defensible.
- Serve as the focal point for QA/QC and be responsible for the oversight and/or review of quality control data such as quality records, control charts, calibration records, documentation of corrective actions and other QA/QC data.
- Lead, plan, organize and support the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory, including but not limited to document control, CAPA, internal audits, control charts & trend analysis, approved suppliers and validation of methods, systems & instrumentation.
- Have direct access to both local and the highest level of management and have sufficient authority, access to work areas, and organizational freedom to initiate corrective action, to recommend solutions to problems through designated channels and to assure that further work is stopped or controlled until proper resolution of a deficiency has occurred.
- Coordinate efforts leading to the acquisition and maintenance of appropriate accreditations, licenses and certificates relevant to the industries that are served by the laboratory.
- Conduct internal audits.
- Maintain Proficiency Testing Program.
- Write, review and revise SOPs and technical reports.
- Ensure the laboratory is fully compliant with all relevant regulatory standards.
- Serve as the laboratory contact for the Ethics and Data Integrity Program.
- Prepare monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory.
- Host and respond to client audits, lead the process to ensure observations are addressed.
- Bachelor's degree in a basic or applied science.
- Minimum of 4 years of laboratory experience and familiarity with laboratory quality systems.
- Familiarity with ISO 17025 and NELAC.
- Thorough understanding of ISO 17025 and NELAC.
- Knowledge of applicable quality systems and accreditation, licensing and/or certification requirements.
- Demonstrated leadership ability.
- Ability to motivate others.
- Ability to lead and work with cross-functional teams.
We are an equal opportunity employer and welcome applications from diverse candidates. Reasonable accommodations will be made for those with disabilities.
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