QC Chemist I

PCI Pharma ServicesMadison, WI
1dOnsite

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management

Requirements

  • 0-3 years relevant Analytical Chemistry experience, preferably in Quality Control
  • Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study
  • Excellent organizational skills and ability to document technical data
  • Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization
  • Ability to multi-task in a dynamic environment with changing priorities
  • Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.

Nice To Haves

  • General knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer and Osmometer is preferred

Responsibilities

  • Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples.
  • Assist in deviation investigation, out-of-specification or aberrant results and process changes
  • Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data
  • Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support
  • Logging and tracking of samples and chemicals.
  • Order chemicals and laboratory supplies as needed
  • Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in compliance with cGMP/GDP requirements
  • May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation
  • Performs routine data generation and problem solving
  • Other duties, as assigned
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