JVT Advisors

Associate II, QC Chemistry

Apply Now

Location:
Employment Type: Contract

Job Description

Contract Length:  6+ months

 

Job Summary:  Perform cGMP QC testing for QC Chemistry, release and stability.

 

Responsibilities:

  • Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering
  • Supports special projects as assigned
  • May assist with Troubleshoots assay methods and equipment.
  • Performs data entry and supports trending
  • Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
  • Supports authoring of SOPs, protocols and reports
  • LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
  • Perform HPLC and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
  • Stability program support
  • Managing/stocking of QC lab supplies
  • Write/revise SOPs, protocols and reports
  • Complete and maintain cGMP documentation for work performed.
  • Participate in authoring quality systems records such as deviations, change controls, CAPAs
  • Establish and maintain a safe laboratory working environment

 

Requirements:

  • Minimum education required: Bachelor’s degree in a relevant scientific discipline
  • Minimum experience required: 0-2 years in a laboratory setting with focus in analytical chemistry
  • Minimum knowledge required: general laboratory operations (Pipette use, pH, reagent prep, etc.)
  • Hands on experience with HPLC instrumentation and Software
  • Minimum skills required:
    • Technical writing
    • Proficiency with Microsoft Office Programs
    • Familiarity with electronic databases (e.g. LIMS, SAP, LMS)
    • Practical working knowledge of HPLC/ UPLC and related software.
  • Strong written and oral communication skills as well as organizational skills
  • Knowledge of industry standards and guidelines
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Jared Potter

Recruiter

He's a natural people person

Can't find your fit?

We get new jobs every day. Send us your resume and we'll let you know when we have the right opportunity for you.

Send Us Your Resume