Quality Control Chemist

1 month ago


Somerset, United States On-Board Companies Full time

.On-Board Services is hiring a Quality Control Chemist in New Brunswick, NJ
For immediate consideration please send your resume to resumes@onboardusa.comSubject Line: Position Title and State you are Located
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 401k.

Position Details:
Position Type: Quality Control Chemist
Job Location: New Brunswick, NJ
Compensation: Up to $28.00-$35 per hour
Length of Assignment: 1 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 3+ years' industry experience as a Chemist or master's degree in chemistry or related scientific field and 1+ 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.


Apply Today
www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

JD# 24-01888
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