Date
11/2020
Location
1200 Airport Road, North Brunswick NJ
Title
Lead, QC Chemist
Department
Quality Control
Reports to
Manager, QC Laboratory
FLSA (Exempt or Non-Exempt)
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, identity, and 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
- Troubleshoots/tests specific batches with HPLC, GC, QC instruments in order to assist in determining the root cause of off-spec product and makes recommendations for ingredient adjustments to meet required specifications.
- Evaluates daily raw data sheets for product samples and release.
- Coordinates annual review of STPS/SOPS.
- 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).
- Maintains floor supervision of QC Chemists for routine testing, if required.
- Prepares and reviews QC related documents as 5% of daily activities.
- Tests samples/raws as assigned and reports the results. Testing activities represent 95% of daily work.
- Prepares and/or reviews Test Procedures, SOPs, and Protocols as assigned.
- Performs maintenance and calibrations of laboratory instruments/equipment.
- Assures GMP compliance according to FDA CFR Part 111.
- 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.
- Must be able to work extended hours as needed and occasional weekends.
- Other duties and responsibilities as assigned by QC director or 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 in Chemistry or related scientific disciplines.
- Five (5) years of basic chemistry techniques (can be academic) is a plus.
- Minimum of 3-5 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 cGMPs 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.):
- Ability to navigate office, lab, and/or plant floor working environments.
- 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 20lbs.
Work Environment (Office, Warehouse, temperature extremes, etc.):
- 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.
- May execute up to 20% of their work at the bench level either standing or sitting on a stool.
- Work performed in a standard office environment is without unpleasant or hazardous conditions.