Tris Pharma, Inc. (****is an innovative specialty pharmaceutical company with an exciting pipeline of both NDA and generic products. Over the past three years Tris’ employee base has grown over 250%: to support this and its’ expectations of continued growth Tris is expanding its’ team by adding a laboratory Metrologist.
Qualified candidates will be responsible for performing routine calibration and instrument performance verification, maintenance, repairs on highly complicated instrument such as HPLC, UPLC, GC, FTIR, UV-VIS etc. as per in-house standard operating procedures as well as performing routine calibration check for balances, pH meter etc. The position has a diverse set of responsibilities. Some of these responsibilities include:
Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
Initiates and drafts investigations; creates, reviews and revises Standard Operating Procedures; assesses critical equipment performance; writes and executes equipment qualification protocols.
Contact and obtains technical information from vendors or service providers; and initiates change control documents.
Train and mentor new and existing chemists on instrument operation and maintenance as appropriate.
Manage laboratory instrument calibration program.
Create and maintain accurate calibrated and qualified instrument list Ensure USP/NF compliance of the laboratory instrumentation.
Analyze samples to evaluate instrumentation performance and troubleshoot the instrument malfunction and or breakdown etc.
Process and report the calibration results using the instrument specific data processing software. Document all activities in a legible manner following established formats and good documentation procedures.
Identify and troubleshoot problems with instrumentation.
Excellent written and oral communications skills required.
Ability and willingness to work additional hours as needed.
Ability to work with cross-departmental teams.
Bachelor’s Degree in Chemistry or related degree with a minimum of 5 years of experience in pharmaceutical or biotechnology industry OR MS degree with 2 years of experience in pharmaceutical or biotechnology industry or an equivalent combination of education and experience REQUIRED
Hands-on experience with analytical instrumentation (UV, IR, HPLC, GC and/or dissolution instruments) REQUIRED
Experience working with FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines PREFERRED
Previous experience performing or assisting in investigations PREFERRED
Previous experience creating, reviewing or revising SOPs PREFERRED
Proficiency with Microsoft Office REQUIRED
Excellent verbal and written communication skills REQUIRED
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. Tris Pharma, Inc. is an Equal Opportunity Employer.