JOBSEARCHER
<Back to Search

Quality Control Specialist

Hello JobseekersIntellectt Inc is hiring for analytical professional for below role with leading Pharmaceutical client. Please apply if interestedJob Title: QC Specialist / QC ScientistLocation: Across US Duration: 6-12+ Month ContractPosition Summary:We are seeking an experienced QC Specialist / QC Scientist to support analytical method validation activities within a regulated laboratory environment. The primary focus of this role will be validation of HPLC methods, with additional support for GC, FTIR, and other standard analytical techniques. The ideal candidate will have hands-on laboratory experience and a strong understanding of GMP and analytical validation requirements.Key Responsibilities:Analytical Method ValidationPerform analytical method validation with a primary emphasis on HPLC, including accuracy, precision, linearity, specificity, robustness, and system suitability testing.Support method validation and verification for GC, FTIR, and other routine analytical techniques.Execute laboratory testing in accordance with approved methods, protocols, and SOPs.Documentation & ComplianceAuthor, review, and execute method validation protocols and reports.Ensure all laboratory activities comply with cGMP, GLP, and data integrity requirements.Maintain accurate and complete documentation, including raw data, notebooks, and electronic records.Instrument & Laboratory SupportOperate, troubleshoot, and maintain analytical instruments as needed.Support instrument qualification, calibration, and routine maintenance activities.Participate in laboratory investigations, deviations, and CAPAs related to analytical testing.Collaboration & SupportCollaborate with QC, QA, and Validation teams to ensure timely execution of validation activities.Support audit readiness and regulatory inspections as required.Required Qualifications:Bachelor’s degree in Chemistry, Analytical Chemistry, Life Sciences, or a related scientific disciplineHands-on experience performing analytical method validation in a GMP-regulated environmentStrong practical experience with HPLC (required)Working knowledge of GC, FTIR, and other common analytical techniquesPreferred Qualifications:Experience with pharmaceutical, biopharmaceutical, or regulated chemical laboratoriesFamiliarity with FDA, ICH (Q2/Q14), and USP analytical method validation requirements

54 matching similar jobs near Louisville, KY