Chemist, Quality Control at US Pharma Lab New Brunswick, NJ

kozmetickesluzby.vecnakraska.sk - Jobboard; New Brunswick (NJ); Sur place; USD 60 000 - 80 000; Plein temps

Résumé du poste

kozmetickesluzby.vecnakraska.sk - Jobboard is looking for a Chemist for Quality Control in New Brunswick, NJ. In this position, you will conduct analysis of raw materials and finished products in compliance with FDA regulations. The role requires a solid foundation in chemistry, attention to detail, and the ability to manage multiple tasks.

Successful candidates will have a BS in Chemistry or a related field and ideally experience in dietary supplements or food production. You will work in a laboratory setting where safety and quality standards are paramount.

Qualifications

• Minimum 1-3 years QC lab work experience in dietary supplements or food.
• Ability to work independently or in a team.
• Solid understanding of cGMP, GLP, and familiarity with regulatory requirements.

Responsabilités

• Perform routine analysis of samples and raw materials in a fast-paced lab.
• Conduct troubleshooting and compliance with regulatory requirements.
• Report results and maintain accurate documentation of tests.

Connaissances

Communication

Chemistry Techniques

cGMP and GLP understanding

Microsoft Word and Excel

Documentation Practices

Time Management Skills

Formation

BS in Chemistry or related field

MS in Chemistry or related field

Outils

HPLC

GC

ICP-MS

Labsolution Software

Waters Empower Lab Software

Description du poste

Chemist, Quality Control 1

New Brunswick, NJ. 1200 Airport Road, North Brunswick, NJ

Date: 06/2020
Location: 1200 Airport Road, North Brunswick, NJ
Reports to: Manager Chemistry Laboratory
FLSA: Non-Exempt

Role Overview

The Chemist, QC 1 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, identity, 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.

The Chemist, QC 2 performs similar routine analysis and additional responsibilities including troubleshooting specific batches, ensuring compliance with regulatory requirements, investigating customer complaints, and performing assigned sampling and testing in an FDA regulated lab environment.

The Chemist, QC 3 performs advanced testing, troubleshooting, and compliance duties, including root‑cause analysis, regulatory compliance, and detailed documentation in an FDA regulated lab environment.

Areas of Responsibility

Level 1

• Analyze organic or inorganic compounds to determine chemical or physical properties, composition, structure, relationships, or reactions.
• Conduct analysis of new samples using a wide variety of techniques, software, and scientific equipment, like HPLC, UPLC, GC & ICP-MS.
• Analyze organic or inorganic compounds to determine chemical or physical properties, composition, structure, relationships, or reactions, using chromatography, spectroscopy, or spectrophotometry techniques.
• Analyze batches of in‑coming raw materials, finished products, dietary supplements, and R&D samples to conduct routine and complex analysis of different samples to classify their physical and chemical identity.
• Conduct Method Validation, Method Verification, and Process Validation for incoming raw materials in FDA GMP‑regulated laboratory.
• Carry out routine calibration of HPLC, LC/MS (API 4000), Analytical balance and microbalance, micropipettes, pH Meter, Evaporator, and others. Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions.

Level 2

• 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.
• Ensure compliance with company and customer specifications as well as federal, state, and local regulatory requirements.
• Investigate customer complaints and provide management with test results information.
• Perform assigned sampling, physical, chemical tests and assays on raw materials, active pharmaceutical ingredients, in‑process, finished, and stability products in an FDA regulated lab environment. Use 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).
• Perform complicated testing with supervisory direction. Document work clearly and perform tests accurately.
• Preparation and review of QC related documents is 5% of daily activities.
• Test samples/raws as assigned and report the results. Testing activities represent 95% of daily work.
• Prepare and/or review Test Procedures, SOPs and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training.
• Comply with all regulatory/in‑house requirements (may include but not 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.

Level 3

• 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.
• Ensure compliance with company and customer specifications as well as federal, state, and local regulatory requirements.
• Investigate customer complaints and provide management with test results information.
• Perform assigned sampling, physical, chemical tests and assays on raw materials, active pharmaceutical ingredients, in‑process, finished, and stability products in an FDA regulated lab environment. Use 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).
• Perform complicated testing with supervisory direction. Document work clearly and perform tests accurately.
• Preparation and review of QC related documents is 5% of daily activities.
• Test samples/raws as assigned and report the results. Testing activities represent 95% of daily work.
• Prepare and/or review Test Procedures, SOPs and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training.
• Comply with all regulatory/in‑house requirements (may include but not 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.

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

Level 1

• BS in Chemistry or related scientific disciplines
• MS in Chemistry, Chemical Engineering, Pharmacy, or related field
• 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.

Level 2

• BS in Chemistry or related scientific disciplines
• MS in Chemistry, Chemical Engineering, Pharmacy, or related field
• 2–4 years basic chemistry techniques (can be academic) is a plus
• Minimum of 2–4 years QC lab work experience with industry experience in dietary supplements, food, or OTC manufacturing.

Level 3

• BS in Chemistry or related scientific disciplines
• MS in Chemistry, Chemical Engineering, Pharmacy, or related field
• 5+ years basic chemistry techniques (can be academic) is a plus
• Minimum of 5+ years QC lab work experience 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 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 work at 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 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.