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Lead, Quality Control Chemist
2 months ago
We are seeking a highly skilled and experienced Quality Control Chemist to join our team at US Pharma Lab. As a key member of our quality control department, you will be responsible for ensuring the quality and integrity of our products.
Key Responsibilities- Perform routine analysis of samples of raw materials, in-process, and finished products to ensure compliance with established test procedures.
- Troubleshoot and test specific batches to determine the root cause of off-spec product and make recommendations for ingredient adjustments.
- Evaluate daily raw data sheets for product samples and release.
- Coordinate annual review of Standard Operating Procedures (SOPs).
- 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 assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products in an FDA regulated lab environment.
- Maintain floor supervision of QC Chemists for routine testing, if required.
- Prepare and review QC related documents.
- Test samples/raws as assigned and report the results.
- Prepare and/or review Test Procedures, SOPs, and Protocols as assigned.
- Perform maintenance and calibrations of laboratory instruments/equipment.
- Assure GMP compliance according to FDA CFR Part 111.
- Comply with all regulatory/in-house requirements when performing the assigned activity.
- Train new QC Chemists.
- 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 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.
The 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.
