Lab Technician - Documentation Writer

About the role

Nivagen Pharmaceuticals, located at 3900 Duckhorn Dr, Sacramento, CA 95834, seeks a Lab Technician - Document Writer to join their team.

Responsibilities

• Prepare, revise, and maintain analytical documents, including:
• Test methods and method validation protocols/reports
• Specifications, Standard Operating Procedures (STPs), Standardized Operating Procedures (SOPs), control sheets, control work sheets, and analytical procedures
• Change controls, deviations, Corrective and Preventative Action (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.

Qualifications

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

Benefits

• Pay range: $25 to $27 per hour
• Yearly bonus and stock options eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage, paid time off, and a 401(k) savings plan.

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.