Lab Technician - Documentation Writer

Nivagenpharmaceuticals; Sacramento (CA); On-site; USD 34,440 - 37,195; Full time

Benefits offered by this job

Yearly bonus

Stock options eligibility

Medical, dental, and vision coverage

Paid time off plan

401k savings plan

Job summary

Nivagen Pharmaceuticals in Sacramento, CA is seeking a Lab Technician - Document Writer. This role involves preparing and maintaining analytical documents to comply with regulatory standards. Candidates must have a high school diploma and proficiency in Microsoft Office. The position offers a competitive hourly wage between $25 and $27, along with benefits.

Nivagen is committed to diversity and equal opportunity in employment.

Responsibilities

• Prepare, revise, and maintain analytical documents, including test methods and reports.
• Manage document lifecycle activities using electronic quality systems.
• Create and route documentation through approval workflows.
• Enter, review, and maintain analytical data workflows.
• Collaborate with QC, QA, R&D, and Regulatory teams.
• Support audits by providing compliant documentation.
• Maintain version control and archival of analytical records.
• Perform additional tasks as assigned.

Skills

Proficiency in Microsoft Office

Experience in document preparation and report writing

Education

High school/GED Degree

Tools

TrackWise

eInfoTree

StarLIMS

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, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job

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.

Qualifications

Education/Experience

• 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 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
• 401k 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.