QC Chemist I

About the role

The primary responsibility of this position is to analyze drug substances, drug products, and/or stability samples using approved laboratory monographs/specifications, Standard Operating Procedures, and USP/NF methodologies to ensure drug products manufactured at and distributed by Pharmaceutical Associates, Inc. meet all quality and compliance requirements.

Responsibilities

• Follow all policies, procedures, SOPs, cGMPs, Work Instructions, and supervisor instructions.
• HPLC/GC Chemists: emphasis in HPLC and/or GC methodology and analyses including all applicable preparations (extractions, dissolution, ISE separation, etc.), and training or experience in chromatographic software and instrument troubleshooting.
• Wet Chemists: emphasis in wet chemistry methodology and analyses such as various titrations, dissolution, USP/NF limit tests, Identifications, TLC, etc.
• Perform analysis of raw materials, bulk, finished product, and stability samples in a timely and compliant manner, as instructed by QC Supervisor, per applicable SOPs, PAI monographs/specifications, and USP methodology to ensure finished goods are acceptable for distribution.
• Document all analyses per applicable SOPs.
• Perform routine laboratory functions to support manufacturing/production and assure that production schedule is met.
• Timely testing and release of manufactured bulk drug products for packaging.
• Maintain clean and organized laboratories; wash labware and pipettes by loading/unloading dishwasher/pipette washer.
• Notify Laboratory Coordinator when reagents, standards, and other materials need to be ordered to ensure all resources available for testing.
• Assist in training and evaluating laboratory personnel to run laboratory equipment for established methods.
• Assist in documentation review of laboratory notebooks.
• Accountable for the accuracy and timeliness of work, attention to detail, and adherence to test method monograph/specifications.
• Work safely in an effective work team, following all safety procedures and policies.
• Perform any other related duties as required or assigned.

Qualifications

BS in Science + 0 years’ experience

Schedule

Weekend Shift - Friday through Sunday, 7am - 7:30pm