QC Metrologist

Siegfried•Pennsville, NJ

22h•$82,000 - $105,000•Onsite

About The Position

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. Maintains all QC Laboratory equipment and stability chambers, AR&D equipment, Environmental equipment, and Production lab balances. Assists 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. Maintains 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. Receives, processes, stores, and tracks the inventory of reference standards and related materials (like chromatographic columns). Performs reconciliation and coordinates the disposal of expired or used standards. Monitors and supports the integrated inventory management process. Works with AR&D on the development of new standards for new methods. Submits 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. Provides reference standard CoA’s to regulatory for submission in current DMF. 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.

Requirements

A B.S. or advanced degree in science
at least 5 years of Metrology experience in a pharmaceutical environment
maintenance training on Agilent HPLC and GC.
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.
Must have a 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)

Responsibilities

Installs and calibrates measurement instruments and systems.
Perform routine maintenance and troubleshooting of measurement equipment.
Analyze measurement data to ensure accuracy and consistency
Develop measurement procedures and protocols
Ensure compliance with industry standards and regulatory requirements
Provide technical support and training to other departments
Document and report measurement and calibration results
Conduct research to improve measurement techniques and technologies
Collaborate with engineers and scientists to resolve measurement challenges
Certify 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.
Assists 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.
Receive, process, store, and track the inventory of reference standards and related materials (like chromatographic columns).
Perform reconciliation and coordinate the disposal of expired or used standards.
Monitor and support the integrated inventory management process.
Works with AR&D on the development of new standards for new methods.
Submits 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.
Provides reference standard CoA’s to regulatory for submission in current DMF.
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.