SUMMARY: The Director of Quality primary function is to oversee the QMS to ensure the facilities and processes adhere to ISO 9001 certification and ISO 17025 accreditation, customer, and internal guidelines. The quality system is integral to ensure the accuracy of results that the lab produces. This position will oversee the quality of the lab results by overseeing all areas that effect the results including, but not limited to: calibrations, chemical grades & expirations, training and all associate records, general method review, sop review, all lab documentation, monitoring and correcting temperature guidelines for lab and equipment, OOS calibrations, OOS results and any other system or procedure that impacts the quality of the lab.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following. Management retains the right to add to or change the duties of the position at anytime. The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.
- Manage quality department staff and direct work, ensure training is completed, conduct performance appraisals, reward and/or discipline employees, address complaints and resolve problems.
- Review and provide trend analysis of maintenance, repair, calibration and operation of instrumentation, thermometers, pipettes, reference standards, incubators and other factors that will affect the quality of lab testing to ensure the compliance with the QMS.
- Review and perform trend analysis of test results and proficiency data to ensure accuracy of testing being generated by the laboratory staff.
- Oversee and approve all training, documentation, calibration activities, supplies used in both labs, OOS investigations, GM and SOP’s, and all other processes that directly effect the quality management system and accuracy of the results the lab produces.
- Perform and document corrective actions, including follow-up monitoring to gauge the effectiveness of those corrective actions.
- Review, investigate and perform trend analysis of OOS test results, customer complaints, and corrective actions using a risk-based approach to improve the QMS.
- Review, develop, and continuously improve the QMS procedures, SOP’s with all record-keeping necessary for the organization to comply with 21 CFR part 111, ISO 9001, ISO 17025, FDA, TGA and other regulatory bodies as required.
- Organize and/or participate in audit activities of internal and external bodies.
- Review and trend outside lab testing results to make sure the same method is being run for similar sample sets then review OOS results communicating with vendor to obtain the OOS report.
- Review and trend vendor incidents to verify vendor qualification and re-qualification annually.
- Perform other roles and responsibilities per the Quality Manual, Quality Procedures and Management as required.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrate strong leadership, organizational and technical skills. Dependability and reliability are key traits.
- Possess excellent communication skills, with the demonstrated ability to interact successfully with vendors and customers.
- Possess excellent math skills and ability to perform statistical analysis for the QMS.
- Be willing to work extended hours, weekends and holidays when needed.
EDUCATION and/or EXPERIENCE: Bachelor of Science in Chemistry, Biochemistry or related field and at least ten years of laboratory experience, lab management and lab quality management or equivalent combination of education and experience.
WORK ENVIRONMENT: Work is carried out in an analytical laboratory. There is considerable exposure to raw materials and chemical reagents. Personal Protective Equipment such as lab coats, gloves, safety glasses and respirators must be worn as defined by safety policy.