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Carex Consulting Group Logo Carex Consulting Group · Quality Control

Scientist I, Quality Control (2nd Shift)

United States, Madison · Job Posted June 28, 2026
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Job Description

Carex is partnering with a Pharmaceutical industry partner to identify a Scientist I, Quality Control (2nd Shift) to support analytical method validation, method transfer, and testing activities for pharmaceutical raw materials, in-process manufacturing samples, finished drug substances, drug products, and stability samples. This role operates within the Quality Control organization and requires a highly experienced scientist capable of working independently, making sound scientific decisions, supporting laboratory operations, and contributing to the successful execution of quality and compliance initiatives. This position is scheduled for second shift, Monday through Thursday, 1:00 PM – 11:30 PM.

Job Responsibility

  • Perform analytical method validation, method transfer, and routine testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples
  • Execute laboratory testing using established analytical methods, procedures, and instrumentation
  • Collaborate with Analytical Development and Manufacturing teams to support validation activities and project timelines
  • Operate, calibrate, maintain, and troubleshoot analytical instrumentation with minimal oversight
  • Demonstrate expertise with analytical technologies including HPLC, GC, LC-MS, Karl Fischer, FTIR, endotoxin plate readers, Raman spectroscopy, and related systems
  • Analyze and interpret data, including tracking and trending stability results and identifying degradation patterns
  • Utilize stability tracking software for data entry, review, approval, and record management
  • Lead technical discussions, scientific problem-solving sessions, and laboratory investigations
  • Identify, troubleshoot, and resolve analytical method, instrumentation, and sample-related issues
  • Review analytical data generated by other QC analysts to ensure accuracy and compliance
  • Draft and support technical documentation including Certificates of Analysis (COAs), deviations, investigations, CAPAs, and related quality records
  • Maintain accurate, complete, and compliant laboratory notebooks and records
  • Support SOP training requirements and assist in training team members on instrumentation and laboratory procedures
  • Communicate laboratory issues, challenges, and project updates effectively to management and cross-functional teams
  • Ensure compliance with cGMP requirements, ICH guidelines, SOPs, and quality standards
  • Maintain a safe, organized, and efficient laboratory environment
  • Serve as a resource and backup to laboratory management when needed
  • Adapt effectively to changing priorities while maintaining high-quality deliverables

Requirements

  • M.S. in Chemistry or a related scientific field with 7+ years of relevant laboratory experience
  • or B.S. in Chemistry or a related scientific field with 9+ years of relevant laboratory experience
  • Extensive knowledge of cGMP requirements, ICH guidelines, and pharmaceutical quality control laboratory operations
  • Demonstrated experience with analytical method validation, method transfers, and routine testing in a regulated environment
  • Strong proficiency with analytical instrumentation, data acquisition systems, and laboratory software platforms
  • Ability to independently execute complex analytical testing and make scientifically sound decisions
  • Experience reviewing technical data and supporting quality investigations and corrective actions
  • Strong troubleshooting skills related to instrumentation, analytical methods, and laboratory processes
  • Excellent written and verbal communication skills
  • Strong organizational skills and attention to detail
  • Ability to work effectively in a collaborative, team-oriented environment
  • Commitment to maintaining compliance, quality, and data integrity standards
  • Ability to meet physical requirements of a laboratory environment, including standing, moving throughout the lab, operating laboratory equipment, and occasionally lifting materials up to 25 pounds
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