Data Reviewer

Job Description

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 :

Knowledge, Skills, and Abilities :

Requirements :

Benefits :

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.