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 weve 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 peoples 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 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
25 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:
Requirements:
Benefits:
Apply:
Send your CV directly to Dr Sundari Chodavarapu
Associate Director Nivagen Pharmaceuticals Inc
Email:
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.