Training and Document Control Specialist

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: Training and Document Control Specialist

The Document Control & Training Specialist will support the development, delivery, and maintenance of training programs related to document control, ensuring compliance with industry standards like ISO, FDA, GMP, or GDP. They ensure that employees understand and follow document control processes, systems, and regulatory requirements, while also supporting audits and quality management initiatives.

Responsibilities:

• Training Development & Delivery: Design and create training materials for QMS and document control processes; deliver instructor-led and virtual sessions across departments and sites.
• Onboarding & Change Management: Provide onboarding training for new hires on document management and QMS procedures; support change initiatives by coaching and training impacted teams.
• Training Effectiveness: Evaluate training outcomes, update content, and ensure alignment with industry standards.
• Compliance Support: Maintain training records, track completion and competency, and provide documentation for audits to demonstrate compliance.
• Curriculum & Reporting: Create/add curriculum assignments in the training system, generate reports, and distribute training results.
• Cross-Functional Support: Partner with other departments to provide first-line training support and improve training programs.

Qualifications:

• Bachelor’s degree or equivalent combination of education and experience.
• 3–5 years in a regulated industry; preferred experience in project management, training, quality systems, or related fields.

Knowledge, Skills, and Abilities:

• Familiarity with regulatory standards (ISO, FDA, GMP, GDP).
• Strong presentation, communication, and facilitation skills.
• Problem-solving and proactive approach to challenges.
• Excellent organization and attention to detail.
• Proficiency in Microsoft Office and Learning Management Systems (LMS).

Job Requirements:

• The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards
• Occasional travel may be required for audits, supplier evaluations, or training
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Familiarity with regulatory standards (ISO, FDA, GMP, GDP).
• Strong presentation, communication, and facilitation skills.
• Problem-solving and proactive approach to challenges.
• Excellent organization and attention to detail.
• Proficiency in Microsoft Office and Learning Management Systems (LMS).
• Additional Information:
• Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs.
• Overtime and weekend work may be required.
• The individual must be available via cell phone (on-call).

Benefits:

• Pay range Competitive
• 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.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.