Kelly Science, Engineering, Technology & Telecom
QC Analytical Scientist
Kelly Science, Engineering, Technology & Telecom, Cleveland, Ohio, us, 44101
QC Analytical Scientist — Compendial Focus
Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a
QC Analytical Scientist
for a year-long engagement at one of our Global clients in
Cleveland, OH .
Job Details
Job Title:
QC Analytical Scientist
Location:
Cleveland, OH
Contract Length:
1+ year
Shift:
Monday- Friday 3pm-11:30pm
Pay Rate:
Commensurate with experience
Job Summary The QC Analytical Scientist will be responsible for executing and managing quality control testing for pharmaceutical raw materials, excipients, drug substances (APIs), and finished drug products to ensure compliance with global compendial standards, primarily the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP). This role is critical for the release of materials and products in a cGMP environment.
Key Responsibilities
1. Compendial Testing & Execution (70%)
Routine Testing:
Perform a wide range of analytical testing (release and stability) on raw materials, APIs, and finished products as per current USP, EP, and JP monographs.
Methodology:
Expertly operate and troubleshoot analytical instrumentation, including:
Chromatography:
High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Thin-Layer Chromatography (TLC) for Assay and Impurity testing.
Physical/Wet Chemistry:
Dissolution, Disintegration, Water Determination (Karl Fischer), Loss on Drying/Ignition, Residue on Ignition, pH, Titrimetry, and Specific Gravity.
Impurity Analysis:
Conduct Elemental Impurities testing using ICP-MS/OES according to USP / and ICH Q3D.
Interpretation:
Review, interpret, and document all test data, ensuring results meet the specified acceptance criteria of the applicable pharmacopeia.
2. Compendial Compliance and Maintenance (20%)
Method Verification:
Execute and document method suitability verification studies for new products or new compendial methods (e.g., per USP) to ensure they are appropriate for the company’s specific material matrix.
SOP & Specification Management:
Draft, revise, and update Standard Operating Procedures (SOPs) and material specifications to reflect the latest editions and revisions of the USP, EP, and JP.
Compendial Monitoring:
Act as a subject matter expert (SME) or liaison for compendial affairs, tracking revisions to monographs and general chapters to ensure proactive compliance within the laboratory.
Deviation Handling:
Participate in investigations for Out-of-Specification (OOS) or Out-of-Trend (OOT) results, providing technical compendial expertise.
3. Documentation and Quality Systems (10%)
Ensure all laboratory activities are performed in strict adherence to cGMP/GLP regulations and company quality policies.
Maintain meticulous laboratory notebooks, equipment logbooks, and electronic records in compliance with data integrity principles.
Support internal and external audits (e.g., FDA, EMA, MHLW) by presenting and defending compendial testing and compliance procedures.
Qualifications Education
Bachelor’s or Master’s Degree in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field.
Experience
Minimum of 3-5 years of hands-on experience in a pharmaceutical or contract testing Quality Control (QC) laboratory.
Demonstrated experience executing and verifying test methods from at least two major pharmacopeias (USP, EP, JP).
Strong working knowledge of cGMP, GLP, and pharmaceutical regulatory requirements.
Expert-level proficiency in analytical instrumentation, particularly HPLC, GC, and Dissolution apparatus.
Exceptional attention to detail and strong technical writing skills for authoring protocols and reports.
Ability to read, understand, and apply complex regulations and technical procedures from different international pharmacopeias.
Strong verbal communication skills for presenting data and compliance strategy to cross-functional teams (e.g., Regulatory Affairs, Manufacturing).
Seniority Level
Associate
Employment Type
Contract
Job Function
Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
QC Analytical Scientist
for a year-long engagement at one of our Global clients in
Cleveland, OH .
Job Details
Job Title:
QC Analytical Scientist
Location:
Cleveland, OH
Contract Length:
1+ year
Shift:
Monday- Friday 3pm-11:30pm
Pay Rate:
Commensurate with experience
Job Summary The QC Analytical Scientist will be responsible for executing and managing quality control testing for pharmaceutical raw materials, excipients, drug substances (APIs), and finished drug products to ensure compliance with global compendial standards, primarily the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP). This role is critical for the release of materials and products in a cGMP environment.
Key Responsibilities
1. Compendial Testing & Execution (70%)
Routine Testing:
Perform a wide range of analytical testing (release and stability) on raw materials, APIs, and finished products as per current USP, EP, and JP monographs.
Methodology:
Expertly operate and troubleshoot analytical instrumentation, including:
Chromatography:
High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Thin-Layer Chromatography (TLC) for Assay and Impurity testing.
Physical/Wet Chemistry:
Dissolution, Disintegration, Water Determination (Karl Fischer), Loss on Drying/Ignition, Residue on Ignition, pH, Titrimetry, and Specific Gravity.
Impurity Analysis:
Conduct Elemental Impurities testing using ICP-MS/OES according to USP / and ICH Q3D.
Interpretation:
Review, interpret, and document all test data, ensuring results meet the specified acceptance criteria of the applicable pharmacopeia.
2. Compendial Compliance and Maintenance (20%)
Method Verification:
Execute and document method suitability verification studies for new products or new compendial methods (e.g., per USP) to ensure they are appropriate for the company’s specific material matrix.
SOP & Specification Management:
Draft, revise, and update Standard Operating Procedures (SOPs) and material specifications to reflect the latest editions and revisions of the USP, EP, and JP.
Compendial Monitoring:
Act as a subject matter expert (SME) or liaison for compendial affairs, tracking revisions to monographs and general chapters to ensure proactive compliance within the laboratory.
Deviation Handling:
Participate in investigations for Out-of-Specification (OOS) or Out-of-Trend (OOT) results, providing technical compendial expertise.
3. Documentation and Quality Systems (10%)
Ensure all laboratory activities are performed in strict adherence to cGMP/GLP regulations and company quality policies.
Maintain meticulous laboratory notebooks, equipment logbooks, and electronic records in compliance with data integrity principles.
Support internal and external audits (e.g., FDA, EMA, MHLW) by presenting and defending compendial testing and compliance procedures.
Qualifications Education
Bachelor’s or Master’s Degree in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field.
Experience
Minimum of 3-5 years of hands-on experience in a pharmaceutical or contract testing Quality Control (QC) laboratory.
Demonstrated experience executing and verifying test methods from at least two major pharmacopeias (USP, EP, JP).
Strong working knowledge of cGMP, GLP, and pharmaceutical regulatory requirements.
Expert-level proficiency in analytical instrumentation, particularly HPLC, GC, and Dissolution apparatus.
Exceptional attention to detail and strong technical writing skills for authoring protocols and reports.
Ability to read, understand, and apply complex regulations and technical procedures from different international pharmacopeias.
Strong verbal communication skills for presenting data and compliance strategy to cross-functional teams (e.g., Regulatory Affairs, Manufacturing).
Seniority Level
Associate
Employment Type
Contract
Job Function
Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr