QC Chemist I

PAI Holdings LLC•Greenville, SC

About The Position

The QC Chemist I analyzes drug substances, drug products, raw materials, bulk and finished products, and stability samples using approved laboratory monographs and specifications, Standard Operating Procedures, and USP/NF methodologies. The purpose is to ensure products manufactured and distributed by Pharmaceutical Associates, Inc. meet quality and compliance requirements. The role performs routine laboratory functions supporting manufacturing and production, documents analyses, and helps ensure manufactured bulk products are tested and released on time for packaging. Chemists may emphasize HPLC/GC methods or wet chemistry methods. The position also includes maintaining laboratory cleanliness and organization, supporting supply readiness, assisting with personnel training and notebook review, and following safety and compliance procedures.

Requirements

  • Bachelor of Science degree in a science field.
  • Zero years of experience required.
  • Ability to perform the essential job functions satisfactorily.
  • For HPLC/GC chemists: emphasis in HPLC and/or GC methodologies and analyses, including applicable preparations such as extractions, dissolution, and ISE separation; training or experience with chromatographic software and instrument troubleshooting.
  • For wet chemists: emphasis in wet chemistry methodologies and analyses, such as titrations, dissolution, USP/NF limit tests, identifications, and TLC.

Responsibilities

  • Follow company policies, procedures, SOPs, cGMPs, work instructions, and supervisor instructions.
  • Perform analyses of raw materials, bulk products, finished products, and stability samples in a timely and compliant manner using applicable SOPs, PAI monographs/specifications, and USP methodology.
  • Document all analyses according to applicable SOPs.
  • Perform routine laboratory functions that support manufacturing and production schedules.
  • Test and release manufactured bulk drug products for packaging in a timely manner.
  • Maintain clean and organized laboratories, including washing labware and pipettes using the dishwasher or pipette washer.
  • Notify the Laboratory Coordinator when reagents, standards, or other testing materials need to be ordered.
  • Assist in training and evaluating laboratory personnel in the use of laboratory equipment for established methods.
  • Assist with documentation review of laboratory notebooks.
  • Ensure work is accurate and timely, attend to detail, follow test method monographs/specifications and safety procedures, and work safely as part of an effective team.
  • Perform other related duties as required or assigned.
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