QA/ QMS Analyst

Job Description

Job Description

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 : QA / QMS Analyst (Full Time)

At Nivagen as QA / QMS Analyst you will be responsible for supporting the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards.

This role involves analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives to ensure the highest standards of product quality and regulatory compliance within the pharmaceutical industry.

Responsibilities :

• Assist in the maintenance and continual improvement of the QMS, ensuring compliance with GMP, FDA, EMA, and other relevant regulatory standards
• Manage QMS documentation, including the creation, revision, and archival of SOPs, quality manuals, and other controlled documents
• Coordinate the implementation of change controls to ensure systematic evaluation and documentation of changes affecting the QMS
• Analyze quality data from various sources, including non-conformances, deviations, and CAPAs, to identify trends and areas for improvement
• Generate detailed reports on QMS performance metrics, providing insights and recommendations to senior management
• Monitor key performance indicators (KPIs) related to quality, such as defect rates, audit findings, and CAPA completion times
• Assist in planning, conducting, and documenting internal audits to ensure compliance with the QMS and regulatory requirements
• Support external audits conducted by regulatory agencies and clients, preparing necessary documentation and providing responses to audit findings
• Track and follow up on audit findings to ensure timely and effective resolution, including the implementation of corrective and preventive actions
• Stay current with changes in regulatory requirements and industry standards, ensuring that the QMS is updated accordingly.
• Conduct periodic reviews of QMS documentation and processes to verify ongoing compliance with applicable regulations
• Participate in risk assessments and contribute to the development of risk mitigation strategies within the QMS framework
• Identify opportunities for improving quality processes and the overall QMS, recommending and implementing enhancements to increase efficiency and effectiveness
• Lead or participate in root cause analysis for quality issues, ensuring that appropriate corrective and preventive actions are identified, implemented, and monitored for effectiveness
• Provide training and support to staff on QMS processes, regulatory requirements, and quality improvement initiatives
• Work closely with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, to ensure alignment on quality objectives and regulatory compliance
• Collaborate with the Supplier Quality Management team to ensure that suppliers meet the company's quality standards and that the supply chain complies with GMP
• Communicate effectively with internal stakeholders to provide updates on QMS activities, audit results, and continuous improvement initiatives
• Review batch production records for completeness, accuracy, and compliance before product release, ensuring that all quality standards are met
• Ensure proper control, accessibility, and regular review of all QMS documents, maintaining a high standard of documentation accuracy and compliance

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 understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines
• Proficient in data analysis with the ability to interpret complex quality data and identify trends
• High level of accuracy and attention to detail, particularly in documentation and data analysis
• Demonstrated ability to conduct root cause analysis and implement effective CAPAs
• Excellent written and verbal communication skills, with the ability to prepare clear and concise reports and documentation
• Familiarity with QMS software and other relevant tools used in quality management and data analysis
• Ability to work effectively in a team environment and collaborate with cross-functional teams

Job Requirements :

• The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards
• Occasional travel may be required for audits, supplier evaluations, or training
• 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.