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QC Metrologist
Verona, WI
Job Description
POSITION OVERVIEW
The QC – Metrologist is the main equipment calibration lead and troubleshoots various equipment with little to no supervision. The Metrologist is also expected to assist Level 1/2/3 QC Chemists with equipment troubleshooting by answering questions and/or contacting vendors as needed. The Metrologist will be responsible for initiating applicable Out of Service Notification (OSN), Process Change Request (PCR), Out of Calibration (OOC) and/or drafting/executing/overseeing qualifications (IQ/OQ/PQ) for new/existing instrumentation in the QC laboratory. The Metrologist will be responsible for drafting and maintaining “Operation, Calibration, and Maintenance” Standard Operating Procedures for equipment or identifying these SOPs that are needed. As directed by management, the Metrologist will initiate a requisition to purchase equipment or to have a vendor come in for on-site repairs. The Metrologist will also be responsible for scheduling Preventative Maintenance and obtaining/renewing coverage plans from vendors for applicable equipment. The Metrologist will assist management with OOC and any other type of investigation related to equipment. The Metrologist will maintain the tracking tool used for lab calibrations.
ESSENTIAL JOB FUNCTIONS
- Follow all CPI cGMP policies and practices
- Follow all CPI safety policies and practices
- Perform calibration of all analytical equipment
- Perform instrument qualifications
- Perform equipment troubleshooting
- Draft equipment IQ/OQ/PQ protocols and protocol summary reports
- Contact equipment vendors
- Maintain analytical equipment
- Maintain cGMP laboratory notebooks and forms
- Perform review of laboratory notebooks and forms
- Maintain a clean, organized laboratory
- Draft/Edit new or existing internal procedures (SOPs)
- Provide formal notifications and reports to management, other departments
- Perform analytical method validation/development work
- Assist with OOC laboratory investigations
- Other duties as assigned by management
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
- Bachelor’s degree in chemistry or other related discipline.
- 3+ years’ experience in the pharmaceutical cGMP environment. An advanced degree will also be considered in place of experience in the pharmaceutical cGMP environment
- Experience with calibrating, using and troubleshooting analytical equipment such as HPLC, GC, and/or dissolution.
- Ability to establish and maintain effective working relationships with co-workers.
- Advanced time management skills to complete assignments/projects in a timely manner with no supervision.
- Advanced problem solving skills to assist management with investigations and troubleshooting of instruments.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Work Hours (i.e. shift)
1st Shift
Salary and Benefits
$18.50 - $23.00/hr
Required Education
Bachelor's Degree
Required Experience
3+ years
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