Biofarma Group
Title : Lead, Quality Control Chemist
Location : USPL / Biofarma - 1300 Airport Road, North Brunswick NJ
Reports to : Manager, Quality Control Laboratory
FLSA : 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
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/MS in Chemistry or related scientific disciplines.
Five (5) years of basic chemistry techniques (can be academic) is a plus.
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.
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.
EEO Statement 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.
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Location : USPL / Biofarma - 1300 Airport Road, North Brunswick NJ
Reports to : Manager, Quality Control Laboratory
FLSA : 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
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/MS in Chemistry or related scientific disciplines.
Five (5) years of basic chemistry techniques (can be academic) is a plus.
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.
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.
EEO Statement 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.
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