Chemist 2, Quality Control

Job Description

Date

05/2023

Location

1200 Airport Road, North Brunswick NJ

Title

Chemist, Quality Control 2

Department

Quality Control

Reports to

Manager, Chemistry Laboratory

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

The QC Chemist II 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 samples solutions and verify quality in accordance with statistical process using sophisticated chromatography and scientific techniques. The Chemist maintains organization 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 GMP 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.
• Work >80% independently on HPLC and other QC instruments after skilled training.
• Participate in troubleshoot of testing related investigations in order to assist in determining the root cause of off-spec product result as per OOS procedure.
• Ensures compliance with company and customer specifications as well as federal, state, and local regulatory requirements.
• Performs complicated testing with supervisory direction. Documents work clearly and performs tests accurately.
• Record and report result as per GDP guidelines and procedures for all the testing performed on daily basis.
• Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned.
• Performs calibrations of laboratory instruments /equipment with supervisory direction/training, if required.
• 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.
• Operation of Microsoft word and excel is on daily basis.
• Assist junior staff in training on specific test, instrument operation and performing troubleshoot of test related issue or instrument related issue to the best available knowledge.
• Must be able to work extended hours as needed and occasional weekends.
• Other duties and responsibilities as assigned.

Other Responsibilities Including Safety:

• Works in a safe and responsible manner to create an injury-free and incident-free workplace.
• Complies with all job-related safety and other training requirements.
• Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

• BS in Chemistry or related scientific disciplines
• One (1) year of basic chemistry techniques (can be academic) is a plus
• Minimum of 3 years QC lab work experience in operating HPLC with industry experience in dietary supplements, food, or OTC manufacturing.

Certifications, Licenses, Credentials:

• N/A

Skills & Ability

• Ability to maintain integrity and honesty at all times and to communicate with transparency.
• Ability to work independently or as part of a team.
• Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11
• Strong working knowledge of Microsoft Word, Excel.
• Good documentation practices and able to write simple, clear reports
• Meets commitments on time and practices time-management skills
• Seeks to identify continuous improvement needs
• Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus.

Physical Requirements (lifting, etc.):

• May execute 90%-100% of their work at the bench level either standing or sitting on a stool.
• Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.
• Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
• On occasion may need to lift up to 35 lbs.
• Ability to navigate office, lab, and/or plant floor working environments.

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

• Approximately 80% of work performed in a laboratory environment which may have unpleasant odors or hazardous conditions.
• Temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

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.