Quality Control Scientist

TekWissen • Cincinnati, OH

3d • Onsite

About The Position

We are seeking a QC Scientist I to support pharmaceutical manufacturing operations through routine residual API and detergent analysis within a Quality Control Analytical Chemistry Laboratory. The role performs chemical testing of residual swab samples using validated analytical methods and techniques including HPLC, Mass Spectrometry, and Total Organic Carbon (TOC). The QC Scientist will review and document analytical results, identify OOS or unexpected results, and ensure all laboratory activities are performed in compliance with GMP, GLP, SOPs, quality, regulatory, and safety requirements.

Requirements

• Bachelor's degree or higher in a Chemistry related stream.
• 1–2 years of experience in pharmaceutical or laboratory chemical testing preferred, including hands-on experience with chromatographic techniques.
• Hands-on and theoretical knowledge of HPLC and Mass Spectrometry required; experience with TOC and residual API/detergent analysis preferred.
• Strong knowledge of instrumental analytical technologies and qualitative/quantitative chemical analysis.
• Understanding of pharmaceutical quality, GMP/GLP, and regulatory requirements.
• Strong analytical, scientific problem-solving, and data-analysis skills, including the ability to evaluate and communicate OOS, unexpected, or non-routine results.
• Ability to read, interpret, and follow SOPs, analytical methods, work instructions, and applicable regulations, with strong attention to detail and commitment to quality and compliance.
• Strong written and verbal communication skills with the ability to document and communicate technical information accurately.
• Ability to multitask, prioritize workload, meet deadlines, and work effectively both independently and as part of a team in a fast-paced laboratory environment.
• Basic mathematical skills, including calculations related to test reliability, variance, and correlation.
• Ability to meet laboratory physical requirements, including prolonged standing, walking, bending, crouching, computer/equipment use, and lifting or moving materials weighing approximately 10–35 lbs.
• Ability to wear required laboratory PPE, including safety glasses, safety shoes, lab coat, gloves, safety apron, and respiratory protection when required.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Nice To Haves

• Experience with TOC and residual API/detergent analysis preferred.

Responsibilities

• Perform routine chemical testing of residual swab samples using established and validated analytical methods.
• Execute residual analysis using HPLC, Mass Spectrometry, and TOC techniques.
• Recognize and report out-of-specification (OOS), unexpected, and non-routine analytical results.
• Perform required instrument calibrations and verifications.
• Prepare test solutions, including diluents and mobile phases.
• Accurately document testing activities, observations, calculations, and analytical results in accordance with laboratory procedures and systems.
• Communicate analytical results and potential issues effectively to appropriate teams.
• Clean, maintain, and organize laboratory work areas and analytical instrumentation.
• Follow SOPs, cGMP, GLP, analytical methods, work instructions, safety guidelines, and quality requirements.
• Manage multiple testing activities and prioritize workload to meet required timelines.
• Participate in training and continuously develop technical and laboratory skills.
• Support additional QC activities and assignments as needed.

What This Job Offers

• Career Level: Entry Level