Senior Metrologist: Pharma Instrumentation Lead

Tris Pharma, Inc.; South Brunswick (NJ); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision, Rx insurance

401K with match

Life insurance

Paid Company Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking an experienced Senior Metrologist to support analytical laboratories with calibration, verification, maintenance and repairs of complex instrumentation (HPLC/UPLC, GC, UV-Vis, FTIR, ICPMS, GCMS, etc.) in compliance with cGMPs and SOPs.

Responsibilities include performing instrument qualifications, investigations of calibration failures, writing SOPs, mentoring junior staff, and ensuring safe disposal of chemical waste; salary range $95 to

Qualifications

• Bachelor's in Chemistry, Engineering or related scientific field and minimum 6 years lab experience in a GMP related industry or minimum 8 years related experience handling analytical equipment in pharmaceutical or biotechnology industry working in Metrology, MV, QC or related laboratories REQUIRED
• Experience with FDA, cGLPs, cGMPs, SOPs and regulatory rules REQUIRED
• Hands-on experience with routine metrology, calibration, maintenance and troubleshooting of analytical instrumentation REQUIRED
• Experience performing or assisting in lab or metrology investigations REQUIRED
• Experience creating, reviewing, or revising SOPs REQUIRED
• Proficiency with Empower and/or other laboratory software REQUIRED

Responsibilities

• Carries out calibration and instrument performance verification, maintenance and repairs on complex instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, GCMS, ICPMS, etc.
• Documents all activities following SOPs and good documentation practices
• Initiates investigations related to calibration failures or instrument issues
• Creates, reviews and revises SOPs related to metrology activities
• Initiates change control related to analytical instruments
• Assesses instrument/equipment performance and compliance with regulations
• Executes instrument qualification protocols and drafts qualification reports
• Trains and mentors lower-level Metrologists

Skills

Metrology expertise

Calibration

Troubleshooting

Documentation

Education

Bachelor's in Chemistry, Engineering or related scientific field

Tools

HPLC/UPLC

GC

UV-Vis

FTIR

GCMS

ICPMS

Muffle Furnace

Viscometers

Density Meters

Melting Point

Dissolution

Autosampler

Polarimeter

Empower

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking an experienced Senior Metrologist to support analytical laboratories with calibration, verification, maintenance and repairs of complex instrumentation (HPLC/UPLC, GC, UV-Vis, FTIR, ICPMS, GCMS, etc.) in compliance with cGMPs and SOPs.

Responsibilities include performing instrument qualifications, investigations of calibration failures, writing SOPs, mentoring junior staff, and ensuring safe disposal of chemical waste; salary range $95 to