Senior QC Chemist

Adare Pharma Solutions Recruiting Team•Vandalia, OH

1d•Onsite

About The Position

The Senior QC Chemist performs complex physical and chemical testing of intermediate and finished products according to written procedures and trains less experienced Chemists as required. Also responsible for testing of cleaning samples for more complex systems and more advanced instrument maintenance. Responsible for timely analytical data reporting based on project timelines.

Requirements

Minimum Bachelor’s degree in Chemistry or closely related field and 5+ years’ experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry
Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices.
Good understanding of chromatography methods and problem solving.
Has a thorough understanding of cGMP and Data Integrity documentation requirements.

Nice To Haves

Bachelor’s Degree preferred, with at least 2+ years of Quality experience in a pharmaceutical or other GMP regulated industry.

Responsibilities

Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
Perform more advanced troubleshooting/maintenance of the instrumentation.
Responsible for more complex physical and chemical testing of raw material, intermediate, and finished products as described in the documented procedures to support product release and process validation protocols.
Trains less experienced Chemists
Demonstrate proficient ability to operate the instrument software applications, set up advanced sequences, troubleshoot software and report data while executing the higher complexity test methods that utilize instruments such as UV, FTIR, GC, and HPLC, and IC.
As required, perform swabbing and analysis of more complex manufacturing equipment with no supervision in accordance with cGMP guidelines.
Provide input on cleaning related issues and investigations.
Evaluate and maintain assigned calibrations for equipment in the laboratory as required and review the required documentation for compliance.
Review instrument qualification documents to support system change control actions and assist vendors during installation and PM’s.
Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines.
Assist Management with writing and completion of investigation sections and product impact as required.
Train others as required as it pertains to LIR/OOS procedures.
Perform method validation and method transfer activities as required.
Assist with customer and regulatory audits as required for Data Integrity and/or instrument file review.
Author, revise and update laboratory test methods and Standard Operating Procedures.
Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures.
Peer review and/or audit others work as required for verification of GMP compliance.
Auditing of laboratory testing data as required.
Demonstrate consistent ability to perform testing with limited investigations and repeat analyses.
Ability to accurately report test data in various formats along with advising less experienced Chemists.
Observes all safety procedures and regulations