Job Description
About the Role:
We are seeking an experienced Quality & Analytical Chemist to join our team. This role is responsible for ensuring product quality, regulatory compliance, and analytical accuracy using advanced lab instrumentation such as HPLC and GC-MS. You will be the key decision-maker for approving or rejecting materials and products, conducting testing, and driving process improvements.
Key Responsibilities:
Quality Duties
- Review 3rd party and in-house lab reports, compare results to finished product spec sheets, and authorize product release when specifications are met.
- Reject any component or product not meeting specifications.
- Approve components, labels, packaging materials, and ingredients for intended use.
- Authorize treatments, rework, or reprocessing to correct deviations (including alk blend and leftover batch processing).
- Release quarantined product upon satisfactory test results.
- Ensure compliance with cGMP CFR 110 and 111, and state/federal regulatory requirements.
- Conduct in-house potency and residual solvent testing using HPLC and GC-MS.
- Perform shelf life validations through accelerated studies or retention sample analysis.
Analytical Duties
- Perform analytical testing using HPLC and GC-MS to assess composition and purity.
- Execute routine and non-routine analysis on raw materials, intermediates, and final products.
- Develop, validate, and optimize analytical methods for identification and quantification.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
- Maintain accurate documentation, analytical reports, and regulatory compliance records.
- Maintain and calibrate lab equipment; troubleshoot and resolve issues promptly.
Requirements
- Minimum 5 years of experience in Analytical Chemistry.
- Experience with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) preferred.
- Strong leadership and communication skills.
- Detail-oriented with excellent problem-solving abilities.
- Able to work independently and collaboratively in a team environment.
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
Job Tags
Full time,