QC Metrologist

About the role

Oversees all metrology activities, including equipment calibration, maintenance, troubleshooting, and documentation to ensure compliance with cGMP, regulatory, and industry standards. Manages reference standards through receipt, qualification, inventory tracking, and disposal while supporting analytical development, regulatory submissions, and continuous improvement of laboratory operations.

Responsibilities

• Installs and calibrates measurement instruments and systems.
• Performs routine maintenance and troubleshooting of measurement equipment.
• Analyzes measurement data to ensure accuracy and consistency.
• Develops measurement procedures and protocols.
• Ensures compliance with industry standards and regulatory requirements.
• Provides technical support and training to other departments.
• Documents and reports measurement and calibration results.
• Conducts research to improve measurement techniques and technologies.
• Collaborates with engineers and scientists to resolve measurement challenges.
• Certifies equipment and processes according to national and international standards.
• Maintains all QC Laboratory equipment and stability chambers.
• Maintains all AR&D equipment.
• Maintains Environmental equipment.
• Maintains Production lab balance.
• Aids in Chemical Development with equipment acquisition and maintenance.
• Troubleshoots all equipment issues in a timely fashion.
• Aids in Lab Investigations that are equipment related.
• Aids in IQ/OQ/PQ documents where a service contract is not applicable.
• Aids in CSV tasks for new instrumentation and routine reviews.
• Acts as the main contact for services reps associated with instrumentation.
• Negotiates service contracts on essential equipment.
• Trains new analysts on maintenance of instruments.
• Writes and/or revises SOP’s associated with reference calibration of instruments.
• Writes capital appropriation requests for new equipment purchases.
• Compiles all routine calibration data for equipment files.
• Maintain calibration records and instrument tagging.
• Assists IT with Empower administration.
• Purchases consumables, reference standards, equipment, etc. when needed.
• Creates purchase requisitions and works with purchasing department.
• Administrator for USP subscription.
• Provides 24-hour support as needed on call.

Requirements

• A B.S. or advanced degree in science with at least 5 years of Metrology experience in a pharmaceutical environment is required as well as maintenance training on Agilent HPLC and GC.
• Expert in cGMP, USP, EP and FDA regulations.
• Technical competence including the understanding of theory and interpretation of all techniques.
• Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software.
• Thorough understanding of computer hardware and software and how it interfaces with analytical equipment.
• Strong organizational skills with the ability to multi-task.
• Prior experience and knowledge in FDA GMPs (21 CFR).

Qualifications

• Ability to recognize what needs to be done, act, and accomplish results.
• Strong oral and written communication skills, including effective listening.
• Demonstrated ability to effectively utilize team resources.

Skills

• Technical competence including the understanding of theory and interpretation of all techniques.
• Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software.
• Thorough understanding of computer hardware and software and how it interfaces with analytical equipment.
• Strong organizational skills with the ability to multi-task.
• Prior experience and knowledge in FDA GMPs (21 CFR).

Benefits

• Competitive performance-based bonus
• Employee Share Matching Plan
• 401(k) Match
• Medical, Dental, and Vision Offerings
• Life, Sickness and Accident insurance, and Long-term disability
• Increased Voluntary Life Insurance (employee and family) (optional)

Pay

The salary for this role is anticipated to be between $82,000 and $105,000

Schedule

Full time