North Brunswick, NJ, United States
The QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established 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 organization and compliance while working in a fast-paced environment with changing priorities.
Essential Duties and Responsibilities
Troubleshoot /test specific batches in order to assist in determining the root cause of off-spec product and make recommendations for ingredient adjustments to meet required specifications.
Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements
Investigates customer complaints and provides management with test results information.
Performs assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical 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 Sprectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer).
Performs complicated testing with supervisory direction. Documents work clearly and performs tests accurately.
Preparation and review of QC related documents is 5%of daily activities.
Testing of samples/raws assigned, and reporting the results from testing activities represents 95% of daily work.
Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned.
Performs maintenance and calibrations of laboratory instruments /equipment with supervisory direction/training.
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.
Must be able to work extended hours as needed and occasional weekends.
Other duties and responsibilities as assigned.
Knowledge Skills & Abilities
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 cGMPâ€™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.
Education and Experience
BS in Chemistry or related scientific disciplines
One (1) year of basic chemistry techniques (can be academic) is a plus
Minimum of 1 -3 years QC lab work experience with industry experience in dietary supplements, food or OTC manufacturing.
Physical Work Environment
May execute 90%-100% of their work at the bench level either standing or sitting on a stool.
Use of PPE as required (gloves, lab coat, face-mask, safety glasses and hair nets)
We offer a comprehensive benefits package. To support the health of our employees and their dependents we provide paid vacation & sick leave,9.5 paid holidays, medical, dental and vision insurance plans. To support their financial well-being we offer a 401K with a generous employer match, 529 college savings plan, life insurance and disability insurances.
USPL is an equal opportunity employer (M/F/D/V)
Job Type: Full-time
Job Type: Full-time
QC Chemist in solid dose pharma or nutraceuticals: 1 year (Required)
United States (Required)
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