Nivagen Pharmaceuticals, Inc.

In Process QA Associate

Sacramento, CA 95834 · Full-time

Sponsorship not specified$70k-$80kDetected 153 days ago

AccessibilitySAPSupply ChainGMPFDA RegulatoryCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft OfficeRegulatory Affairs

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.
If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

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.

Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards.
Ability to gown and work within controlled cleanroom environments.
Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.).
Ability to stand for extended periods during manufacturing oversight activities.
Knowledge, Skills, and Abilities:
Education/Experience:
Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience.

0-3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments.
Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR).
Strong organizational skills and attention to detail.
Effective written and verbal communication skills.
Ability to work independently while collaborating within cross-functional teams.
Basic knowledge of deviation management, CAPA, and change control processes preferred.
Familiarity with electronic systems such as ComplianceWire, TrackWise, SAP, LIMS, or similar eQMS platforms preferred.
Proficiency in Microsoft Office applications.

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

Yearly bonus eligibility
Medical, dental and vision coverage
Paid time off plan
Nivagen offers a wide variety of benefits and programs to support health and well-being

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.
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.
to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
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: In Process 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.

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.