Chemist, Quality Control

Role Overview

Level 1

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, 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 .

Level 2

The Chemist, QC 2 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 organization and compliance while working in a fast-paced environment with changing priorities.

Level 3

The Chemist, QC 3 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 organization and compliance while working in a fast-paced environment with changing priorities.

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.

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Level 2

• Troubleshoot /test specific batches in order to assist in determining the root cause of off-spec product and makes 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 Spectrophotometer, 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.
• Test of samples/raws as assigned and reports the results. 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.

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Level 3

• Troubleshoot /test specific batches in order to assist in determining the root cause of off-spec product and makes 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 Spectrophotometer, 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.
• Test of samples/raws as assigned and reports the results. 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.

• 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.

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Level 2

• BS in Chemistry or related scientific disciplines
• MS in Chemistry, Chemical Engineering, Pharmacy, or related field
• 2-4 year of 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

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Level 3

• BS in Chemistry or related scientific disciplines
• MS in Chemistry, Chemical Engineering, Pharmacy, or related field
• 5 year of 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’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.