QC Chemist II

Job Title: Chemist I, II, or III Department: Quality Control

Reports To: Quality Control Supervisor Status: Full Time/ Exempt

JOB SUMMARY:

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 PAI meet all quality and compliance requirements. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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.
• esponsible 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 SOP's, PAI monographs/specifications, and USP methodology to ensure finished goods are acceptable for distribution.
• Responsible for documentation of all analyses per applicable SOP's and performance of routine laboratory functions to support manufacturing/production and assure that production schedule is met.

Responsible for 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 review of laboratory documentation.
• Accountable for the accuracy and timeliness of work, attention to detail, and adherence to test method monograph/specifications. Must follow all applicable Standard Operating Procedures, including all safety procedures and policies.
• Perform other duties as assigned.
• For Chemist II, in addition to the tasks listed above, the analyst is able to independently perform multiple different types of testing without significant guidance from management. Analyst will execute OOS investigation plans and routinely serve as second analyst in laboratory investigations. Perform technology transfers and provide coaching and mentorship to junior chemists.
• For Chemist III, in addition to the tasks listed above, the analyst will routinely troubleshoot critical analytical and technical issues, serve as investigator for laboratory CAPAs, and revise raw material and finished product monographs to ensure compliance with compendial methods.

EDUCATION AND/OR EXPERIENCE:

This position requires a Bachelors' degree in chemistry, biochemistry, biology or other science field, and/or equivalent combination of education and experience. Working knowledge of Microsoft Office Suite is required. Experience with OpenLab and LIMS software is preferred. Experience in chromatographic software (e.g. Empower) is preferred.

For Chemist I, B.S. in a science field along with 0-2 years applicable laboratory experience is required.

For Chemist II, M.S. or PhD in a science field along with 0-2 years applicable laboratory. experience is required. B. S. in a science field along with 3 years applicable laboratory experience is required.

For Chemist III, B.S. in science + 6 years' experience, M.S. in science + 4 years' experience, PhD + 2 years' experience.

KNOWLEDGE, SKILS & ABILITIES:

This position requires the individual be organized, detail-oriented, and self-motivated and to apply advanced mathematical concepts and operations. The ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Decision making, communication, planning and critical thinking skills are a must. Analytical ability / problem solving, along with accuracy is required. Applicable experience in an analytical laboratory preferred, experience in GMP is ideal. Standard laboratory equipment, including viscometer, centrifuge, analytical balance, conductivity meter, dissolution, apparatus, Karl Fisher, density meter, pH meter, HPLC, GC/FID, GC/Headspace, IR, UV-Vis, AA, polarimeter, particle sizer and analyzer and refractometry.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Frequently lift up to 30lbs. and occasionally up to 50 lbs. is required. This position is regularly exposed to toxic chemicals.

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled.