In 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.

About the Job

Title of the Position: In Process QA Specialist (Full Time)

• Ensure pharmaceutical products meet quality standards during the manufacturing process through routine on-the-floor QA oversight, line clearances, in-process checks, and documentation.
• Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks.
• 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.

Qualifications

• 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.

Job Requirements

• 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 environments. Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.). Ability to stand for extended periods during manufacturing oversight activities.
• Work Environment / Schedule: Primarily day shift, Monday–Friday. May require flexibility to support manufacturing operations, including occasional off-shift or weekend coverage.
• Work Location Assignment: On-site / Manufacturing Facility. This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment. Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius).

Benefits

Pay range $70,000 - $80,000 per Year
Yearly bonus eligibility
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
401k savings plan

Additional Information

Nivagen to afford equal opportunity for employment to all individuals 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 status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.