Quality Control Chemist

Serovia; Branchburg Township (NJ); In loco; USD 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

Serovia is seeking a QC Chemist to join our sterile injectable manufacturing startup in New Jersey. You will perform analytical testing, validate methods, and support release of materials and finished products under cGMP guidelines.

You will maintain instruments, assist in investigations, and mentor junior team members while collaborating across Manufacturing, QA, Validation, and Regulatory Affairs to ensure compliant batch release and continuous improvement.

Competenze

• Bachelor’s or master’s degree in chemistry, pharmaceutical sciences, or related field.
• 5+ years of experience in pharmaceutical QC laboratory, preferably sterile injectables.
• Hands-on experience with validated analytical methods and GMP-compliant operations.
• Strong knowledge of FDA cGMP, USP, ICH, and data integrity standards.

Mansioni

• Perform analytical testing of materials and products using validated methods.
• Develop and validate new analytical methods to support product development and process optimization.
• Ensure compliance with cGMP, FDA, USP, and data integrity standards.
• Prepare and review test protocols, reports, COAs, deviations, and investigations.
• Maintain instruments, calibrations, and preventive maintenance.
• Support regulatory inspections and audits with audit-ready documentation.
• Collaborate with cross-functional teams to ensure batch release and compliance.
• Train and mentor QC chemists on lab procedures and GLP practices.
• Lead continuous improvement for laboratory efficiency and data integrity.

Conoscenze

Analytical thinking

Attention to detail

Communication skills

Coaching / mentoring

Team collaboration

Formazione

Bachelor’s degree in chemistry

Master’s degree in pharmaceutical sciences

Strumenti

HPLC

GC

UV-Vis

FTIR

TOC

Descrizione del lavoro

The Quality Control (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. The QC Chemist will also coach, mentor, and train QC Chemists in the lab.

Key Responsibilities:

• 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.).
• Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.
• Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.
• Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.
• Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.
• Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.
• Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.
• Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.
• Coach and train new QC Chemists and mentor them regarding proper lab procedures, cGLP, and safe practices.
• 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.
• 5+ 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.
• Strong analytical and problem-solving skills.
• High attention to detail and accuracy in laboratory work and comfortable coaching others.
• Solid understanding of data integrity and documentation practices and able to coach others.
• 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.