Live opening · Posted 3 days ago
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About the role
Description supplied by the original job listing.
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.
Basic Minimum Qualifications:
Bachelor's degree in Chemistry, or other science-related field of study, or relevant equivalent experience
Computer skills, including proficiency with Microsoft Office
Professional working proficiency in English is a requirement, including the ability to read, write and speak in English.
Authorization to work in the United States without restriction or sponsorship
Ideal Candidates will have:
Previous experience working in quality in a lab or similar setting
Motivation to be accurate and produce high quality work with minimal supervision
Planning, organization, work management (multi-tasking) and follow-up skills
Quality-orientation with high attention to detail
Effective written and verbal communication skills
Computer literacy with Windows-based programs; MS Office, office equipment, and good typing skills.
Ability to accept changes in schedules and versatility of workload; willingness to adjust to corporate needs
Ability to follow detailed verbal and written instructions
A clear understanding of priorities
Employment type
Full-time
Work arrangement
No
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