QC Metrologist

Your 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.

Your Profile

• 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 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.
• Aids 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.
• Reference Standards Receive, process, store, and track the inventory of reference standards and related materials (like chromatographic columns).
• Performs reconciliation and coordinates the disposal of expired or used standards.
• Maintains and supports the integrated inventory management process.
• Works with AR&D on the development of new standards for new methods.
• SUBMIT ALL STANDARDS FOR TESTING TO APPLICABLE IN-HOUSE OR EXTERNAL LABS.
• Writes and/or revises SOPs associated with reference standards.
• Ensures USP standards are current to the most recently issued USP Catalog.
• Compiles standard qualification data for reference standard files.
• Maintains reference standard files.
• Supports sales with customer standard requests.
• Repackages standards from bulk containers.
• Tracks standard inventory.
• Arranges for disposition of expired/out of spec material.
• Adheres to all applicable cGMP and SHE regulations.
• Performs any other laboratory task deemed necessary by the Director of Quality Control.
• Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.

Supervisory Responsibilities

This position has no direct reports.

Education, Experience, Certification And Licensures

• 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.

Knowledge, Skills And Abilities

• 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.
• 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.

Benefits

• Additional 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

N/A