Quality Control Chemist

On-Board Companies; Franklin Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in New Jersey is hiring a Quality Control Chemist to perform crucial testing in a regulated laboratory environment. The successful candidate will ensure compliance with industry standards while executing stability tests and maintaining high-quality documentation. This role supports the timely disposition of manufactured products and requires a strong background in chemistry and analytical methods.

Qualifications

• Bachelor's degree in chemistry and relevant industry experience required.
• Knowledge of GMP and USFDA guidelines is crucial.
• Familiarity with analytical instrument techniques is beneficial.

Responsibilities

• Perform routine stability tests and evaluate test results.
• Write technical documents and maintain accurate lab notebooks.
• Ensure compliance with SOPs and cGMP standards.

Skills

Analytical skills

Knowledge of GMP

Attention to detail

Education

Bachelor’s degree in chemistry

Master’s degree in chemistry or related field

Tools

HPLC

GC

IR

Metrohm titrator

Job description

• On-Board Services is hiring a Quality Control Chemist in New Brunswick, NJ!

For immediate consideration please send your resume to Subject Line : Position Title and State you areLocated About Us :

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as k.

Position Type : Quality Control Chemist

Job Location : New Brunswick, NJ

Compensation : Up to $$ per hour

Length of Assignment : year with a possibility of extension

The Quality Control Chemist for the drug product testing team reports to the Finished Product / Stability Supervisor. The primary purpose of the job is to perform testing and make calculated decisions on the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of timely disposition of manufactured products.

Responsibilities

• Perform routine stability tests using stability indicating methods including dissolution, assay, related compounds, chromatographic purity etc. Additionally, individual shall be aware of commonly used wet analysis techniques, particle size distribution, density, water determination by KF, and other tests to perform test according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
• Follow written operating procedures to perform routine tests like dissolution, assays, blend uniformities, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like Dissolution, UV, HPLC, GC, IR etc.
• Evaluate test results and decide acceptability of the samples based on the test results. Review and release the raw data, documentation, and results for certificate of analysis.
• Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
• Other duties related to departmental activities may be assigned by management based on situation and necessity.

Qualifications :

• Bachelor’s degree in chemistry or related scientific field and + years’ industry experience as a Chemist or master’s degree in chemistry or related scientific field and + years’ industry experience as a Chemist
• Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP / ICH requirements)
• Ability to make observations with instruments and analysis techniques.
• Basic knowledge of instrument techniques and software for instruments like HPLC, GC, IR, KF, Metrohm titrator, etc. Previous experience with Empower is plus.
• Ability to carry out necessary computations and to draw and interpret graphs.
• Basic knowledge of method validation, method transfer, and method verification of the analytical methods is plus.
• Knowledge of basic to advance level of computer skills.

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