Senior QC Chemist

Summary

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.

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

Qualifications

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

Physical Demands

• The Employee is required to stand, walk, push, pull, twist, reach overhead, and bend to the floor
• The employee may be required to wear personal protective equipment (PPE) during certain phases of the operation; such as high noise areas from machinery, exposure to a variety of chemicals, or exposure to dust, mists, and fumes.
• occasionally move items or equipment
• occasionally required to climb ladders and/or steps to reach equipment
• Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
• Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.