QC Chemist I

GENERAL DESCRIPTION OF POSITION

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions.

HPLC/GC Chemists:

Shall have an 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:

Shall have an emphasis in wet chemistry methodology and analyses such as various titrations, dissolution, USP/NF limit tests, Identifications, TLC, etc. Responsible for performing 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. Responsible for documentation of all analyses per applicable SOPs. Responsible for performance of routine laboratory functions to support manufacturing/production and assure that production schedule is met. Responsible for the timely testing and release of manufactured bulk drug products for packaging. Responsible for maintaining 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. For following applicable Standard Operating Procedures, including all safety procedures and policies. For working safely in an effective work team. Perform any other related duties as required or assigned.

EDUCATION / EXPERIENCE BS

in Science + 0 years' experience

ADDITIONAL INFORMATION

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify. EEO Employer / Veteran / Disabled