Job Title: Senior QC Chemist

Job Summary

The Senior QC Chemist is responsible for the preparation, testing, review, and release of commercial, stability, developmental, and raw material samples within established turnaround times in a Quality Control laboratory. This role ensures all activities are executed in compliance with internal quality systems, regulatory requirements, and QC performance metrics.

Key Responsibilities

• Perform routine analytical testing, data review, and release using methodologies such as HPLC, GC, Dissolution, FTIR, and other relevant techniques across multiple sample types (raw materials, in-process, finished product, stability, validation, development, and complaint samples).
• Prepare and standardize reagents and laboratory solutions.
• Ensure all work is documented in accordance with Good Documentation Practices (GDP).
• Generate, review, and approve analytical data, reports, and supporting documentation.
• Review data packages for accuracy, GMP compliance, and adherence to specifications.
• Review and approve chromatographic data using laboratory software systems (e.g., Chromeleon or equivalent).
• Release test results to Quality Assurance within established timelines.
• Communicate testing status, delays, and investigation updates to key stakeholders.
• Review peer work for accuracy and compliance.
• Lead and/or support method transfers from development to validated QC methods.
• Author and review specifications for raw materials, in-process materials, and finished products.
• Monitor compendial updates and assess impact on internal methods and specifications.
• Operate, calibrate, maintain, and troubleshoot analytical instrumentation; perform minor repairs as needed.
• Lead or support laboratory investigations (OOS, deviations, CAPAs), including:
  • Defining investigation strategies
  • Identifying root causes
  • Recommending corrective and preventive actions
• Support product complaint investigations.
• Author and review technical documents including SOPs, protocols, reports, and specifications.
• Perform additional laboratory and operational tasks, including:
  • Sample management and coordination with external labs
  • Inventory control and ordering supplies
  • Waste disposal and laboratory housekeeping
• Maintain compliance with regulatory and internal requirements for documentation and equipment records.
• Follow all safety protocols and apply sound laboratory practices.
• Collaborate cross-functionally and contribute to multidisciplinary project teams.
• Drive continuous improvement initiatives in quality, efficiency, and processes.
• Provide training and mentorship on analytical techniques and laboratory procedures.
• Analyze and present data to support decision-making.
• Participate in internal and external audits as needed.
• Communicate potential scheduling risks or delays proactively.

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline (advanced degree preferred).
• 5+ years of experience in a pharmaceutical QC laboratory or regulated environment.
• Strong knowledge of analytical techniques including chromatography, spectroscopy, and wet chemistry.
• Hands-on experience troubleshooting analytical instrumentation.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong attention to detail, organization, and commitment to quality.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and laboratory systems.
• Excellent written and verbal communication skills.
• Demonstrated technical writing expertise.
• Ability to interpret analytical data and make sound, data-driven decisions.
• Proven ability to follow SOPs, test methods, and regulatory requirements.
• Flexibility to take on additional responsibilities as business needs evolve.

Additional Information

• This role operates within a regulated GMP laboratory environment.
• Responsibilities may be adjusted based on organizational and project needs.