Quality Control Chemist

WhiteCrow Research; Branchburg Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A global injectables company seeks a QC Chemist in Branchburg Township, New Jersey. The successful candidate will play a vital role in quality assurance at a newly established greenfield pharmaceutical manufacturing facility. Responsibilities include performing analytical testing and ensuring compliance with regulatory standards. Ideal candidates have a degree in chemistry and at least 3 years of experience in pharmaceutical QC laboratory operations. Strong analytical skills and attention to detail are essential.

Qualifications

• 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.).
• Knowledge of FDA cGMP regulations, USP standards, and data integrity expectations.

Responsibilities

• Perform analytical testing of raw materials and finished products using validated methods.
• Develop and validate new analytical methods as required.
• Ensure compliance with cGMP, FDA, USP, and other regulatory standards.

Skills

Analytical instrumentation

Problem-solving skills

Attention to detail

Organizational skills

Time management

Communication skills

Education

Bachelor’s or master’s degree in chemistry or related field

Tools

HPLC

GC

UV-Vis

FTIR

Job description

We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house talent acquisition teams.

About our client

Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.

By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.

About the role

• 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.

As a Quality Control Chemist, you will be responsible for...

• Performing 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.).
• Developing and validating new analytical methods as required to support product development, regulatory submissions, and process optimization.
• Ensuring compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.
• Preparing and reviewing laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.
• Maintaining laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.
• Supporting laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit‑ready documentation and laboratory practices.
• Assisting in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.
• Collaborating with cross‑functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.
• Participating in training programs to ensure technical competency and adherence to evolving regulatory requirements.
• Contributing to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.

What you already have...

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.
• 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.

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Health Care Provider