SUMMARY

The position supports analytical requirements of both R&D and QA/QC operations. The Metrologist is responsible for assisting in the oversight of equipment maintenance and calibration program for laboratory equipment in a controlled GMP pharmaceutical laboratory environment. This includes performing while under supervision the preventative maintenance, repair, calibration, installation, and qualification requirements to ensure that the laboratory equipment is functioning properly and available for use daily.

This position will also assist management in the areas designated by supervisors, e.g. solving problems, reviewing experimental data, writing protocol/SOP and training support staff as necessary.

RESPONSIBILITIES

• Conducts calibration, qualification (IQ/OQ/PQ) and maintenance of laboratory analytical instrumentation (i.e., pH meter, HPLC, dissolution apparatus, UV, IR, Muffle Furnace, Disintegrator, KF titrator, Conductivity meter, Balances, and any other laboratory analytical instrumentation as required).
• Instrument logbook maintenance: issue/archive/retire logbooks as needed.
• Maintains appropriate documentation (records and lab notebooks) as required by SOP’s.
• Write, revise, and update the Standard Operating Procedures (SOP’s) for analytical equipment.
• Complies with all current Good Manufacturing Practices (cGMP) with all relevant regulatory requirements and safety requirements, Standard Operating Procedures (SOPs) and company policies and procedures.
• Coordinate of both internal and external calibration activity, shipping, and receiving etc.
• Maintain and file instrument related documentation to QA.
• Work with 3rd party vendors to ensure company standards and documentation procedures are met.
• Support for ordering the Lab supplies and coordinating with the delivering vendor.

Knowledge Of:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Up-to-date instrumentation and the following instruments: UV/IR, HPLC and TLC.
• Ability to read and interpret documents and instructions, such as safety rules, Laboratory Instruments operating and maintenance instructions, and SOPs.
• Computer applications and programs related to laboratory applications such as HPLC, FTIR, TOC analyzer etc.,
• Mathematics including statistics.
• Ability to report data and observations accurately, both in writing and verbally Sample preparation techniques.
• Spectroscopic techniques and chromatographic system.
• Must have basic computer knowledge, including MS Excel, Word, and Outlook.
• Demonstrates ability to prioritize conflicting demands and executes assigned tasks within established schedule

QUALIFICATIONS

• Education : Bachelors of Science in Chemistry or related science from an accredited college of university and minimum of two (2) years of metrology service work experience; or two or more years of experience as a Lab metrologist/ Analytical instrumentation experience (usage and/or calibration) or an equivalent combination of training and experience.
• Knowledge/Skills: The ability to work successfully in both a team/matrix environment as well as independently. The ability to work in a fast paced environment, manage priorities and maintain timelines for multiple projects
• Mental Requirements : Ability to perform basic calculations, read, write, communicate and handle stress produced by time pressure, customer demands, etc.
• Physical Requirements : Ability to walk, perform visual tasks related to a pharmaceutical manufacturing facility. Incumbents in this class are subject to extended periods of sitting, standing,

COMPENSATION : $75,000