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Quality Assurance Specialist - 1st Shift - Environment Testing

27 days ago
Full time role
In-person 路 Lancaster, PA, US... more

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. 

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