Senior QC Chemist: Lead Testing & GMP Excellence

Adare Pharma Solutions; Vandalia (OH); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Adare Pharma Solutions in Vandalia, Ohio is seeking a Senior QC Chemist to perform complex testing of intermediates and finished products, train junior staff, and ensure data integrity and regulatory compliance. You will operate advanced instruments (UV, FTIR, GC, HPLC, IC), maintain calibrations, and support audits.

The role requires a Bachelor’s degree in Chemistry or related field with 5+ years in pharma QC or related labs, and a strong grasp of cGMP/data integrity.

Qualifikationen

• Bachelor’s degree in Chemistry or closely related field.
• 5+ years’ experience in a Chemistry Laboratory, Quality Control or R&D in the pharmaceutical industry.
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices.
• Thorough understanding of cGMP and Data Integrity documentation requirements.

Aufgaben

• Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
• 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.
• Evaluate and maintain assigned calibrations for equipment in the laboratory as required and review the required documentation for compliance.
• 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

Kenntnisse

GMP knowledge

Quality control

Chromatography understanding

Ausbildung

Bachelor’s degree in Chemistry or closely related field

Jobbeschreibung

Adare Pharma Solutions in Vandalia, Ohio is seeking a Senior QC Chemist to perform complex testing of intermediates and finished products, train junior staff, and ensure data integrity and regulatory compliance. You will operate advanced instruments (UV, FTIR, GC, HPLC, IC), maintain calibrations, and support audits.

The role requires a Bachelor’s degree in Chemistry or related field with 5+ years in pharma QC or related labs, and a strong grasp of cGMP/data integrity.