Nivagen Pharmaceuticals, Inc.
Document Control Training Manager
Sacramento, CA 95834 · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$9,778 more — $99,778 — moves this role to Level IV and 4 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $99,778 would place this position at wage Level IV. That figure is within the posted range, and I'd like to target it. This role classifies under "Training and Development Specialists" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Training and Development Specialists (13-1151) · Sacramento-Roseville-Folsom, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people.
- 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.
- If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
Responsibilities
- Lead and manage the document control team, including supervision of Document Control Specialists and Training Coordinators.
- Establish and maintain the controlled document hierarchy (policies, SOPs, work instructions, forms, batch records) in compliance with 21 CFR Part 211 and ICH Q10.
- Manage the electronic document management system (eInfotree or equivalent), including user access, document workflows, version control, and archival.
- maintain training matrices for all GMP personnel.
- Lead the SOP Harmonization Program, coordinating batch scheduling and reviews across Validation, Microbiology, DEA, SAP, and other functional groups.
- Track and report document control and training KPIs including SOP revision cycle time, overdue training, training completion rates, and document backlog metrics.
- Support internal audits and FDA/regulatory inspections by providing training records, controlled document packages, and SOP status reports.
- Collaborate with QMS management on quality council presentations, management review inputs, and continuous improvement initiatives.
- Ensure training records are complete, accurate, and audit-ready; maintain training matrices for all GMP personnel.
- Nivagen Pharmaceuticals is seeking a Document Control & Training Manager to lead the document control and GMP training programs across all quality and manufacturing operations.
Requirements
- Occasional travel may be required for audits, supplier evaluations, or training
- Familiarity with regulatory standards (ISO, FDA, GMP, GDP).
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related field.
- Minimum 7-10 years of experience in QA, managing document control and training programs in sterile pharmaceutical manufacturing, with at least 2 years in a supervisory or managerial role.
- Strong knowledge of 21 CFR Parts 210, 211, and 212
- Experience with electronic document management systems (eInfotree, TrackWise or similar).
- Strong written and verbal communication skills with the ability to author clear, compliant SOPs and training materials.
- Experience leading SOP harmonization or standardization projects across multiple departments.
- ICH Q7 and Q10
- and FDA expectations for controlled documents and training systems in sterile manufacturing environments.
- Proven experience developing and managing GMP training programs specific to sterile and aseptic operations, including gowning qualification, aseptic technique training, and cleanroom behavior.
- Excellent organizational and project management skills with the ability to manage multiple concurrent SOP review and training initiatives.
- Job Requirements:
- The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards
Nice to have
- Experience supporting FDA or regulatory inspections is a plus.
Compensation
- Develop, implement, and manage the site-wide cGMP training program including new hire orientation, role-based training curricula, annual retraining, and training effectiveness assessments.
- Pay range: $90- $140K based upon experience
Benefits
- 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
- Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
- 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.
Company info
- 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:
- The ideal candidate is a hands-on leader who can build scalable document control and training systems from the ground up while maintaining compliance with FDA/cGMP and ICH requirements.
Visa & Work Authorization
- iduals 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 s
This listing is sourced directly from Nivagen Pharmaceuticals, Inc.'s careers page and normalized into a canonical job model.