The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility. This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards. The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.

 

Key Responsibilities:

  1. Prepare SOPs, test procedures, and product/material specifications
  2. Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).
  3. Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.
  4. Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.
  5. Participate in reviewing laboratory documentation including test protocols, reports, COAs, and change control records.
  6. Maintain laboratory instruments, arrange for routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.
  7. Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.
  8. Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.
  9. Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.
  10. Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.
  11. Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.

 

Qualifications / Experience:

  • Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.
  • 3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.
  • Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.
  • Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.
  • Experience supporting laboratory investigations and regulatory inspections.

 

Skills / Competencies:

  • Strong analytical and problem-solving skills.
  • High attention to detail and accuracy in laboratory work.
  • Good understanding of data integrity and documentation practices.
  • Ability to work both independently and as part of a team in a dynamic startup environment.
  • Excellent organizational, time management, and communication skills.
  • Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.