Senior Analytical Chemist
6 days ago
We are a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market.
Job OverviewNivagen is committed to excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
Salary and BenefitsWe offer a competitive salary range of $75,000-$85,000 per year, with eligibility for a yearly bonus. Our benefits package includes medical, dental, and vision coverage, paid time off, and a 401k savings plan.
Job DescriptionThe Quality Control Chemist will be responsible for conducting analytical tests on pharmaceutical products, ensuring they meet regulatory standards such as those set by the FDA and ICH. This role involves performing tests on raw materials, intermediates, and finished dosage forms to guarantee product safety, efficacy, and quality in compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
- Operate and maintain analytical instruments such as GC, GC-MS, LC-MS, UPLC, and HPLC, which are equipped with UV-Vis, PDA, and CAD detectors.
- Ensure proper calibration and regular maintenance of laboratory equipment to guarantee accuracy and precision in results.
- Assist in developing and validating analytical methods for new products, ensuring compliance with regulatory guidelines, including those from ICH and FDA.
- Perform qualitative and quantitative analyses on raw materials, in-process materials, and finished products using validated methods to ensure compliance with required specifications.
- Conduct stability studies on products following ICH guidelines, adhering to stability protocols, and documenting results for regulatory submissions.
- Investigate deviations and out-of-specification (OOS) results, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
- Ensure all testing adheres strictly to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory standards.
- Implement ICH Q2 (R1) guidelines for method validation and participate in internal and external audits to maintain laboratory compliance.
- Collaborate with R&D, production, and quality assurance teams to support product development and commercialization efforts, and provide assistance during regulatory inspections.
To succeed in this role, you should have a Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field, and 1-5 years of experience in a pharmaceutical quality control laboratory.
LocationThis position is located at Nivagen Pharmaceuticals Inc. in Sacramento, CA, within the Sacramento Metropolitan Region.
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