Clifton, NJ 07012
Up to $65,000 a year – Full-time, Part-time

About the Company

Located in Clifton, New Jersey, CS Analytical represents the only cGMP, FDA-regulated laboratory exclusively designed and built to serve the container and package testing needs of the pharmaceutical, biotechnology, and medical device industries. The CS Analytical Team is comprised of the world’s leading experts when it comes to regulated container qualification testing. The mission of the CS Analytical team is simple: share their experience, knowledge and commitment to regulatory compliance with each client and bring “exceeds expectations” service back to the contract lab market, which has seen a decline in consultative competency and customer satisfaction over recent years. Test services offered will cover CCI method development, validation, and analysis, as well as USP/EP/JP physical performance tests and physicochemical tests for all common or unique primary packaging components and systems.

Description of Role

A CS Analytical Laboratory Analyst will perform USP and EP Testing Methods specific to container and package testing in an FDA regulated cGMP laboratory setting. Test methods include USP < 661>, < 671>, < 660>, < 670> , < 381> and container integrity testing specific to USP < 1207> to include method development and validation.

Analysts are responsible for all technical aspects of tests assigned to them, including setup, analysis, documentation, reporting, and result interpretation. Working with laboratory management and quality, they may be asked to support investigations or to author or update new SOPs, protocols, or qualification documents within their respective domain.

Key Tasks

  • Perform testing to established USP test methods specific to container and package systems
  • Adhere to all aspects of a strict cGMP, FDA regulated quality system to include following all assigned SOP’s and Test Methods, documentation and training requirements.
  • Assist with equipment calibration and qualifications and overall maintenance

Technical Requirements

Candidates that have the following technical experience will be given priority

  • Direct knowledge of USP test methods with specific experience in container and package testing methods to include USP < 661>, < 671>, < 660>, < 381>.
  • Prior work Experience with the following instruments: DSC, FTIT, UV-Visible Spectrophotometer .
  • Experience with ICP-MS and HPLC specific to USP < 661.1> and < 661.2> testing is a plus
  • Experience using an electronic notebook program.

Continued growth and training on new services and instrumentation are intended for the right candidate.

Salary will be determined based upon experience of the specific test methods referenced.

We offer a flexible work schedule and will hire both full-time and part-time candidates.

Job Types: Full-time, Part-time

Pay: Up to $65,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible schedule
  • Health insurance
  • Paid time off
  • Referral program

Schedule:

  • 8 hour shift
  • Monday to Friday

Supplemental Pay:

  • Bonus pay

Education:

  • Bachelor’s (Preferred)

Experience:

  • cGMP: 2 years (Required)

Typical start time:

  • 8AM

Typical end time:

  • 5PM

Benefit Conditions:

  • Only full-time employees eligible

Work Remotely:

  • No

COVID-19 Precaution(s):

  • Personal protective equipment provided or required
  • Sanitizing, disinfecting, or cleaning procedures in place