Jobs / United States / Nivagen Pharmaceuticals INC
Document Control Training Manager
Nivagen Pharmaceuticals INC · 🇺🇸 Sacramento, CA 95834
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Nivagen Pharmaceuticals INC paid sponsored hires in similar roles3 certified filings for “Process Engineer Manager” (Industrial Engineers) in CA: $75k–$130k, median $130k. Most were filed at wage level III (67%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Nivagen Pharmaceuticals INC
The US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Nivagen Pharmaceuticals INC →
About the role
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: Nivagen Pharmaceuticals is seeking a Document Control & Training Manager to lead the document control and GMP training programs across all quality and manufacturing operations. This is a managerial role responsible for overseeing SOP lifecycle management, training program development and execution, regulatory compliance of controlled documents, and supervision of Document Control Specialists and Training Coordinators within a sterile pharmaceutical manufacturing environment. 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. Responsibilities: • Lead and manage the document control team, including supervision of Document Control Specialists and Training Coordinators. • Own the SOP lifecycle from drafting through review, approval, issuance, periodic review, and retirement across all GMP departments. • 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. • Develop, implement, and manage the site-wide cGMP training program including new hire orientation, role-based training curricula, annual retraining, and training effectiveness assessments. • Ensure training records are complete, accurate, and audit-ready; 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. Qualifications : • 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 supervis