Nivagen Pharmaceuticals, Inc.

Nivagen Pharmaceuticals, Inc.

Manufacturing QA Specialist

Sacramento, CA 95834 · Full-time

Sponsorship not specifiedDetected 13 days ago
AccessibilitySupply ChainGMPFDA RegulatoryCommunicationCollaborationProblem SolvingOrganizational Skills

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odds of building a lasting career here

40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

7 transfer filings in the last year, covering 7 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • For over a decade, we've remained steadfast in our commitment to 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.

Responsibilities

  • Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements.
  • Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks.
  • Support the authoring, review, and approval of QA Manufacturing procedures, controlled documents, and Master Batch Records to ensure compliance with cGMP, regulatory requirements, and internal quality standards.
  • Participate in GMP area walkthroughs and support inspection readiness activities.
  • Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support.
  • Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement.
  • 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.

Requirements

  • Required Skills/Abilities:

Skills

  • Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation
  • High level of attention to detail, particularly in identifying quality deviations and documenting production processes
  • Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods
  • Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards
  • Excellent communication skills, both verbal and written, for effective collaboration and documentation
  • Strong organizational skills and attention to detail.
  • Effective written and verbal communication skills. <span data-ccp-props="{"134233279":true,"134245417":

Benefits

  • 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 Inc., Sacramento, CA
  • 3900 Duckhorn Dr, Sacramento, CA 95834
  • About the Job:
  • Title of the Position: Manufacturing QA Specialist (Full Time)
  • At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process.
  • This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements.
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