Specialist, Metrologist

JOB DESCRIPTION

Date

06/2020

Location

1200 Airport Road, North Brunswick NJ

Title
Specialist, Metrologist

Department

Quality Control

Reports to

Vice President, Quality Control

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

The Senior Metrologist is accountable for driving results in a fast-paced environment by performing diagnostics and repair of instrumentation including HPLC, GC, Environmental Chambers, FTIR, ICP-MS, TOC, Microwave digestors and other QC analytical & microbiology equipment(s). Perform instrument calibrations in a pharmaceutical quality environment, maintaining calibration of metrology standards, and completing and reviewing calibration documents. Advanced knowledge of NIST standards and regulations in a regulated environment is required. It is preferred that this candidate has working knowledge of US Food and Drug Administration regulations for quality unit.

Areas of Responsibility

• Maintain the instrument quality program which includes IQ, OP, PQ, Preventive maintenance and Calibration program of Analytical and microbiological instruments. Schedule the weekly, monthly, bi-annual, quarterly and annual PM / calibrations / certifications in timely manner.
• Troubleshooting and Repairs of analytical and microbiological Instruments, Biosafety Cabinet, Laminar hood, Shimadzu HPLC systems, GC system, KF titrator, Metrohm & Mettler auto titration, dissolution apparatus, stability Chamber's, TOC analyzer, ICP-MS, auto digestion CEM & Anton-Paar and other QC related instruments and equipment(s).
• Instrument asset management and life cycle.
• Inform QC management for downtime of any lab instrument.
• Act as point of contact for all instrument operation and troubleshooting activity.
• Coordinate with outside lab instrument manufacturer and service providers for repairs and maintenance of equipment.
• Write the deviation reports for any planned or unplanned failure of any lab instrument or equipment.
• Download and monitor the Relative humidity / temperature data from data loggers. Maintain the records for Temperature / Humidity data for chambers, incubators, refrigerators, storage cabinets, microbiology cleanrooms.
• If outside preventive and corrective maintenance required, contact the vendor and/or service provider and negotiate on the quotes.
• Coordinate with QC purchasing to purchase parts for instruments, execute the quotes and request for quotes for CM / PM.

• Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity.
• Good knowledge of FDA regulations to maintain calibration, maintenance, repair records and documentation.

• Must be able to work extended hours as needed and occasional weekends.
• Other duties and responsibilities as assigned.

Other Responsibilities Including Safety:

• Works in a safe and responsible manner to create an injury-free and incident-free workplace.
• Complies with all job-related safety and other training requirements.

• Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

• AA /BS degree in related scientific disciplines or equivalent
• Minimum 3 years in metrological techniques in pharmaceuticals / nutraceuticals
• Minimum of 5 years QC lab work experience with industry experience in dietary supplements, food, or OTC manufacturing using or troubleshooting chromatography, mass spectroscopy, spectroscopy, environmental chambers and other QC related instruments.
  Certifications, Licenses, Credentials:

• N/A

Skills & Ability

• Ability to maintain integrity and honesty at all times and to communicate with transparency.
• Ability to work independently or as part of a team.
• Solid understanding of cGMP's and GLP and is familiar with 21 CFR Part 11
• Strong working knowledge of Microsoft Word, Excel.
• Good documentation practices and able to write simple, clear reports
• Meets commitments on time and practices time-management skills
• Seeks to identify continuous improvement needs
• Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus.

Physical Requirements (lifting, etc.):

• Ability to navigate office, lab, and/or plant floor working environments.
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.
• Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
• On occasion may need to lift up to 35 lbs.

• Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
• On occasion may need to lift up to 35 lbs,

Work Environment (Office, Warehouse, temperature extremes, etc.):

• Approximately 80% of work performed in a standard office environment is without unpleasant or hazardous conditions.
• May execute up to 20% of their work at the bench level either standing or sitting on a stool. Temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship