Process QA Associate

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 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.

Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834

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. 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.

• In this role, you will:
• Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements.
• Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations.
• Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation.
• 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.
• Assist with product disposition activities and quality review processes under supervision.
• Promote a culture of quality, compliance, and operational excellence within the organization.

• 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 Compliance Wire, Track Wise, 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.
• Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs.

Physical / Mental Requirements

• Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards.
• Strong analytical and problem-solving skills.
• Ability to gown and work within controlled cleanroom…