Sr. Metrologist

Tris Pharma•Monmouth Junction, NJ

6d•Onsite

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines. They have an immediate opening in their Metrology department in Monmouth Junction, NJ for an experienced Senior Metrologist. The Sr. Metrologist supports Analytical laboratories by performing routine calibration and instrument performance verification, maintenance and repairs on highly complicated instrumentation. This role collaborates closely with laboratory management, carries out laboratory work to support laboratory activities, and performs special projects as assigned. The incumbent also writes and assists with investigations related to instrument calibration failures or other instrument-related issues.

Requirements

Bachelors 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, Method Validation (MV), Quality Control (QC) or related laboratories
Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations, and guidelines
Hands on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical instrumentation (i.e., HPLC/UPLC, GC, Dissolution Apparatus and Autosamplers, UV-Vis, Density Meter, Balances, Ovens, Viscometers, Melting Point apparatus, Refractometer, Polarimeter, Media Dispenser Ezfill, etc.)
Experience performing or assisting in laboratory or metrology investigations
Previous experience creating, reviewing, or revising SOPs
Proficiency with Empower and/or other laboratory software

Responsibilities

Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
Performs routine calibration and instrument performance verification, maintenance, and repairs on highly complicated instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, GCMS, ICPMS, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.
Processes and reports calibration results using instrument specific data processing software; Documents all activities in legible manner following established formats and good documentation procedures
Initiates, writes and assists investigation related to instrument calibration failures or another instrument related issues
Creates, reviews and revises SOPs related to metrology activities
Initiates change control related to analytical instrument
Assesses critical analytical instrument/equipment performance
Executes analytical instrument qualification protocols and drafts qualification reports
Contacts and obtains technical information from vendors or service providers
Analyzes samples to evaluate instrumentation performance and troubleshoot instrument malfunction and/or breakdown, etc.
Trains and mentors lower-level Metrologists and assists them during routine metrology
Safely and properly dispose of chemical waste, as needed
Complies with all company policies and procedures, including safety rules and regulations and adheres to cGMPs and current Good Documentation Practices (cGDPs)