Laboratory Metrologist

Upsher-Smith Laboratories•Maple Grove, MN

18d

About The Position

The Laboratory Metrologist is responsible for performing routine and non-routine calibrations and maintenance for equipment in the Upsher-Smith Analytical Laboratory with minimal support in compliance with cGMP, FDA and other regulatory requirements. Responsible for creation and execution of instrument qualification with support. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Essential Duties Perform maintenance and calibrations for intermediate laboratory instruments (e.g. HPLC, UPLC, GC). Subject matter expert for operation and troubleshooting of intermediate laboratory instruments. Assess impact and provide recommendations for requested changes (Change Control) in qualified laboratory instruments with support. Support and maintain the qualified state of laboratory instruments in compliance with USL, FDA and other regulatory requirements. Write and execute qualification documents (IQ/OQ/PQ, etc.) and technical reports with support. Participate on project teams. Intermediate understanding of USP chapters related to calibration and qualification of equipment with ability to evaluate proposed changes and their impact. Author deviations with support. Prioritize workload independently and tracks completion of high priority activities. Plan maintenance and calibration activities around lab testing activities and be willing to shift priorities to meet business needs. Ensure that tasks performed are consistent with company policies and Code of Conduct. Correspond with outside vendors, compendial groups (USP, ICH, etc.) and other departments with minimal supervision. Review and revise SOPs used for instrument operation/maintenance/calibration. Manage project timelines with support and notify management if deadlines will not be met. Propose solutions to reduce the impact. Provide leadership and training for junior calibration technicians. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Requirements

Bachelor's Degree in Chemistry, Engineering or related field with a minimum of 4 years' experience, in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment, preferably in the pharmaceutical industry, OR;
Master's Degree a minimum of 2 years' experience in calibrating and maintaining HPLC, GC, IR, AA, and UV and other laboratory equipment. preferably in the pharmaceutical industry, OR;
High School Diploma or equivalent with 10 years' experience working in a laboratory setting, with a minimum of 4 years maintaining and/or calibrating laboratory equipment, preferably in a pharmaceutical industry.
Demonstrate cooperation and professionalism with all members of the USL organization.
Aids in ensuring a safe environment in the laboratory.
Strong verbal and written communication skills, ability to work independently and with others and to multi-task.
Experience or training in Word or Excel and other computer software.
Required to wear safety glasses and lab coat while in the lab area, may be required to wear other protective equipment such as goggles, gloves, ear protection, etc.

Responsibilities

Perform maintenance and calibrations for intermediate laboratory instruments (e.g. HPLC, UPLC, GC).
Subject matter expert for operation and troubleshooting of intermediate laboratory instruments.
Assess impact and provide recommendations for requested changes (Change Control) in qualified laboratory instruments with support.
Support and maintain the qualified state of laboratory instruments in compliance with USL, FDA and other regulatory requirements.
Write and execute qualification documents (IQ/OQ/PQ, etc.) and technical reports with support.
Participate on project teams.
Intermediate understanding of USP chapters related to calibration and qualification of equipment with ability to evaluate proposed changes and their impact.
Author deviations with support.
Prioritize workload independently and tracks completion of high priority activities.
Plan maintenance and calibration activities around lab testing activities and be willing to shift priorities to meet business needs.
Ensure that tasks performed are consistent with company policies and Code of Conduct.
Correspond with outside vendors, compendial groups (USP, ICH, etc.) and other departments with minimal supervision.
Review and revise SOPs used for instrument operation/maintenance/calibration.
Manage project timelines with support and notify management if deadlines will not be met.
Propose solutions to reduce the impact.
Provide leadership and training for junior calibration technicians.