Lead, Quality Control Chemist

Job Description

Job Description

Job Description

Date

02 / 2024

Location

1300 Airport Road, North Brunswick NJ

Title

Lead, Quality Control Chemist

Department

Quality Control

Reports to

Manager, Quality Control Laboratory

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

The Lead, QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and / or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and / or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains & organizes testing’s and compliance while working in a fast-paced environment with changing priorities.

Areas of Responsibility

• Performs assigned sampling, physical, chemical tests and assay on raw materials, active dietary ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer.
• Troubleshoots HPLC, GC, QC instruments for specific tests in order to assist in determining the root cause of aberrant results and help in performing Lab investigations / OOS.
• Evaluates daily raw data sheets for product samples and release, if needed.
• Coordinates annual review of STPS / SOPS as per USPL procedures.
• Prepare new methods and test procedures for new or existing raw materials and finished products.
• Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements.
• Perform floor supervision of QC Chemists for routine testing, if required.
• Prepares and reviews QC related documents during and finishing of testing of sample. Submit all testing related documents like data sheets, chromatograms, spectras, instruments print outs in timely manner to Qc Documentation department to release the batch of raw material / finished product.
• Prepares and / or Reviews Test Procedures, SOP's and Protocols as assigned.
• Performs maintenance and calibrations of laboratory instruments / equipment, if required to help in-house calibrations.
• Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines.
• Complies with all regulatory / in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity.
• Trains new QC Chemists to perform instrumental testing.
• Must be able to work extended hours as needed and occasional weekends.
• Other duties and responsibilities as assigned by QC in-charge / management.

Other Responsibilities Including Safety :

Requirements

Education & Qualification :

Certifications, Licenses, Credentials :

Skills & Ability

Physical Requirements (lifting, etc.) :

Work Environment (Office, Warehouse, temperature extremes, etc.) :

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

USPL is proud to be an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Benefits And Compensation : Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including : medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

Office Hours :

8 : 30 AM - 5 : 00 PM

9 : 00 AM - 5 : 30 PM