In Process QA Specialist

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.

Job Location:

Nivagen Pharmaceuticals Inc., 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. 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.

Responsibilities:

• Identify and oversee critical control points in the manufacturing process to prevent quality deviations
• Continuously monitor production processes to ensure that manufacturing team operate within specified parameters and meet quality standards
• Collect in-process samples at various stages of production for testing and verification. Preparation, review and approval of standard operating procedures (SOPs)
• Coordinate in-process testing of intermediate products for critical quality attributes, such as potency, purity, pH, and uniformity, to ensure they meet specifications
• Oversee environmental monitoring in cleanrooms and other controlled areas, ensuring compliance with sterility and particulate requirements
• Review and verify the completeness and accuracy of batch production records during the manufacturing process
• Document any deviations or non-conformances detected during production, ensuring they are properly logged and addressed in a timely manner
• Lead or support investigations into process deviations, identifying root causes and assessing their impact on product quality
• Implement and monitor corrective and preventive actions (CAPA) to resolve issues and prevent recurrence
• Ensure that all in-process activities comply with GMP, FDA, EMA, and other relevant regulatory standards
• Assist during internal and external audits by providing necessary documentation and explaining in-process controls and testing procedures
• Identify opportunities for process improvements that enhance product quality and manufacturing efficiency
• Provide training to production staff on quality standards, proper documentation practices, and in-process testing procedures
• Work closely with production, quality control, and engineering teams to resolve quality issues and implement process improvements
• Collaborate with supplier quality management to ensure that raw materials and components meet quality requirements before and during the manufacturing process
• Ensure that all in-process activities are documented and conducted in accordance with regulatory guidelines and company SOPs
• Participate in risk assessments to identify potential quality issues and implement mitigation strategies

Qualifications:

Education/Experience:

• A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology or Related Sciences from an accredited institution is preferred
• Additionally, a minimum of Two to five years of experience in in in-process quality assurance or a related role within a pharmaceutical or GMP-regulated environment, or equivalent experience in related fields, is necessary

Knowledge, Skills, and Abilities:

• 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

Job Requirements:

• May require working in shifts, including nights or weekends, depending on production schedules
• Adherence to safety protocols, including the use of personal protective equipment (PPE) and compliance with GMP standards, is mandatory
• This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Pay range $75,000-$85,000 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.