The Quality Assurance Specialist is responsible to support the Quality Assurance department and laboratory staff; assist with the certification processes (renewals, scope additions, Proficiency Test Sample tracking and reporting, etc.); process laboratory and client requests for information; maintain internal documentation for metrological testing of laboratory supplies/equipment; manage documentation in support of routine investigations and corrective action follow-up.
Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Apply applicable current regulations based on assignment, such as EPA, TNI, PALA,
- State/Regulatory programs, and ISO17025.
- Perform all QA functions in compliance with quality policy and regulatory requirements
- Manage Proficiency Testing program through ordering of PT samples, entry into LIMS, distribution to the laboratories and reporting of results. Initiate investigation requests for failed parameters.
- Assist with submissions (applications, records, etc.) for maintenance of laboratory accreditations.
- Perform transcription review as needed (i.e., PT entries, QAPP tables, accreditation scopes)
- Maintain the list of ISO-Approved Suppliers
- Make and communicate monthly SOP/forms review assignments for QA staff
- Communicate monthly report deadlines to QA department, format monthly reports entries, distribute the report to management
- Maintain metrological calibration records for balances, weights, thermometers, etc.
- Coordinate the scheduling of these activities with the laboratories and the vendor
- Help gather needed information for external audits
- Support QA staff in performance of Data Miner electronic data audits by compiling initial data to be reviewed by the Senior/Principal Specialist
- Review data reports from DI water monitoring, storage blanks, preservation checks, etc.
- Issue investigation requests as needed.
- Route investigations and audits once they have been approved and closed by designated QA staff. File routing documentation within the investigation database
- Work with Client Services department to organize and approve subcontract laboratories: sending requests for information, tracking responses, etc.
- Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories
- Monitor the QA Group email Inbox; assign individuals to requests as needed based on area of representation.
- Maintain inventory of office supplies for the department; submit supply orders as needed
- Conducts all activities in a safe and efficient manner. Follow all required safety protocols.
- Performs other duties as assigned
Role is full time, 1st shift, M-F 9:00am-5:00pm.