Job Description
About the Company: Nivagen is 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. For over a decade, we've remained steadfast in our commitment to the core values of 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. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job: Title of the Position:
Data Reviewer We are hiring an experienced Data Reviewer to support our analytical lab. In this role, you will review all day-to-day QC-related work with special emphasis on HPLC, IPC-MS, LC-MS/MS, GC-MS, and/or HRMS data to ensure accuracy, compliance, and data integrity in a GMP/GLP environment.
Key Responsibilities - Review raw MS data, chromatograms, spectra, and reports.
- Verify calibration curves, QC results, sample sequences, and calculations.
- Check peak identification, mass accuracy, and peak integration.
- Ensure compliance with SOPs, ICH, USP, FDA, and ALCOA+ principles.
- Collaborate with analysts to resolve discrepancies.
- Review all logbook entries, lab notebook entries, datasheet entries, protocols, and reports.
- Prepare SOPs as and when needed and provide training for the analysts.
Qualifications :
Education/Experience: - Degree in Chemistry or related field
- 2–5+ years' experience with LC-MS, GC-MS, or HRMS
- Familiarity with MS software (UNIFI, Mass Lynx, , Trace Finder, Empower, Chromeleon etc.)
- Strong attention to detail and documentation skills.
Knowledge, Skills, and Abilities: - Experience in preparing reports.
- Proficiency in Microsoft Office.
- Proficiency in Notebook, Calculations, and performing internal audits.
Requirements: - Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius)
Benefits: - Pay range $25 to $28 an hour
- Yearly bonus and stock options eligibility
- Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
- Medical, dental, and vision coverage
- Paid time off plan
- 401 (k) savings plan
Apply: Send your CV directly to Dr Sundari Chodavarapu
Associate Director, Nivagen Pharmaceuticals Inc
Email: bchodavarapu@nivagen.com
Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
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