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 role helps ensure products manufactured and distributed by Pharmaceutical Associates, Inc. meet quality and compliance requirements and are acceptable for distribution. The position supports manufacturing and production schedules through routine laboratory work and timely testing and release of bulk drug products for packaging. Chemists may focus on HPLC/GC methods or wet chemistry methods, depending on their area of assignment. The role also includes laboratory upkeep, documentation, equipment training support, and assistance with notebook reviews. The schedule is Monday through Thursday, 4:00 p.m. to 2:30 a.m.

Requirements

Bachelor of Science degree in a science field.
No prior experience required.
For HPLC/GC chemists: emphasis in HPLC and/or GC methods 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 methods and analyses such as titrations, dissolution, USP/NF limit tests, identifications, and TLC.
Ability to perform the essential job functions satisfactorily.

Responsibilities

Follow all policies, procedures, SOPs, cGMPs, work instructions, and supervisor instructions.
Perform analyses of raw materials, bulk products, finished products, and stability samples according to applicable SOPs, PAI monographs and specifications, and USP methodology.
Document all analyses in accordance with 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 a dishwasher or pipette washer.
Notify the Laboratory Coordinator when reagents, standards, or other testing materials need to be ordered.
Assist with training and evaluating laboratory personnel in the use of laboratory equipment for established methods.
Assist with reviewing laboratory notebooks.
Ensure accuracy and timeliness of work, attention to detail, adherence to test methods and specifications, and compliance with safety procedures and policies.
Work safely and effectively as part of a team.
Perform other related duties as required or assigned.