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
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.
The duties and responsibilities described for each level are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Management reserves the right to modify, assign, or reassign duties and responsibilities at any time based on business needs.
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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.
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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.
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Evaluates daily raw data sheets for product samples and release, if needed.
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Coordinates annual review of STPS / SOPS as per USPL procedures.
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Prepare new methods and test procedures for new or existing raw materials and finished products.
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Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements.
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Perform floor supervision of QC Chemists for routine testing, if required.
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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.
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Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned.
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Performs maintenance and calibrations of laboratory instruments /equipment, if required to help in-house calibrations.
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Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines.
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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.
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Trains new QC Chemists to perform instrumental testing.
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Must be able to work extended hours as needed and occasional weekends.
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Other duties and responsibilities as assigned by QC in-charge / management.
Other Responsibilities Including Safety:
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Works in a safe and responsible manner to create an injury-free and incident-free workplace.
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Complies with all job-related safety and other training requirements.
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Keeps management informed of area activities and of any significant problems.
Education & Qualification:
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BS/MS in Chemistry or related scientific disciplines.
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Five (5) years of basic chemistry techniques (can be academic) is a plus.
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Minimum of 5 years QC lab work experience in handling HPLC, GC, KF, Dissolution, DT and other sophisticated lab instruments in dietary supplements, food or OTC / Pharmaceutical manufacturing industry.
Certifications, Licenses, Credentials:
Skills & Ability
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Ability to maintain integrity and honesty at all times and to communicate with transparency.
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Ability to work independently or as part of a team.
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Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11.
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Strong working knowledge of Microsoft Word, Excel.
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Good documentation practices and able to write simple, clear reports.
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Meets commitments on time and practices time-management skills.
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Seeks to identify continuous improvement needs.
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Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters
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Empower Lab Software a plus.
Physical Requirements (lifting, etc.):
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Ability to navigate office, lab, and/or plant floor working environments.
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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.
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Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
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On occasion may need to lift up to 20lbs
Work Environment (Office, Warehouse, temperature extremes, etc.):
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Work is regularly performed inside a laboratory environment where 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.
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May execute up to 20% of their work at the bench level either standing or sitting on a stool.
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Work performed in a standard office environment is without unpleasant or hazardous conditions.
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.
Job Description Acknowledgement
I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.
