Lab Technician - Documentation Writer

About the role

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, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 Title of the Position: Lab Technician - Document Writer

Responsibilities

• Prepare, revise, and maintain analytical documents, including:
• Test methods and method validation protocols/reports
• Specifications, STPs, SOPs, control sheet, control work sheet and analytical procedures
• Change controls, deviations, CAPAs, and investigations
• Ensure documents comply with cGMP, FDA, ICH, and internal quality standards.
• Manage document lifecycle activities using electronic quality systems.
• Create and route documentation through approval workflows in TrackWise and eInfoTree .
• Enter, review, and maintain analytical data and workflows in StarLIMS .
• Collaborate with QC, QA, R&D, and Regulatory teams during document preparation and review.
• Support internal and external audits by providing accurate and compliant documentation.
• Maintain version control, archival, and traceability of analytical records.
• Perform any additional tasks as assigned by management.

Requirements

• Education/Experience:
• High school/GED Degree.
• Knowledge, Skills, and Abilities:
• Experience in assisting in preparing reports and writing documents.
• Proficiency in Microsoft Office.
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius)

Benefits

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