The Metrologist is responsible for maintaining the instrument quality program including the maintenance, qualification, and repair of laboratory instrumentation and equipment. The Metrologist must work with Lab Operations, E-Systems, and Quality Assurance to assure compliance with processes and procedures to reduce risks and improve compliance and productivity.
location: Exton, Pennsylvania
job type: Permanent
salary: $75,000 - 85,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
- Maintain the instrument quality program which includes:
- AIQs
- Preventative maintenance
- Basic Troubleshooting
- Repairs
- Instrument asset management and life cycle.
- Laboratory facilities equipment.
- Assist with the SAP calibration and maintenance module.
- Assist on strategies to control costs, reduce risks, and improve productivity.
- Write and execute IQs, OQs, PQs, and validation protocols, as necessary.
- Write documents such as laboratory investigations, work instructions, SOP's, etc., as assigned.
- Collaborate with Laboratory Operations to determine qualifications required for new instrumentation.
- Collaborate with Laboratory Operations and Facilities Management to maintain and improve Laboratory facility.
- Utilize SAP to perform change control, corrective and preventative actions and investigations.
- Collaborate with vendors/suppliers to ensure instrument needs within Analytical Services are communicated and implemented.
- Provide support and assistance with laboratory equipment, instrument, and facilities 24/7 to maintain laboratory operations.
- Maintain metrics for instrument repair history and response time.
- Assist with audits.
- Keep current with new technologies and cGMP regulations.
- Implement continuous improvement/lean activities and events for the group.
- Perform other duties as assigned.
qualifications:
- Bachelor's degree in a life science discipline (biology, chemistry, forensic science) or equivalent experience
- Minimum 3 years' experience in analytical instruments/metrology.
- 2-3 years' experience in repair, maintenance, and calibration of analytical instrumentation
- Instrumentation troubleshooting skills
- Knowledge of calibration accuracy testing requirements and metrology.
- Experience in cGMP laboratory preferred.
- Understanding of regulatory guidelines such as Z540, 17025, ISO, and GMP.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company's safety and quality policy at all times.
skills: Metrology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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