QA/ QMS Analyst

$75,000 - $85,000/Yr

Nivagen Pharmaceuticals - Sacramento, CA

Full-time - Mid Level

Sacramento, CA

Merchant Wholesalers, Nondurable Goods

About the position

At Nivagen Pharmaceuticals, the QA/QMS Analyst plays a crucial role in supporting the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards. This position is integral to ensuring that the highest standards of product quality and regulatory compliance are maintained within the pharmaceutical industry. The QA/QMS Analyst will be responsible for analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives. This role requires a proactive approach to quality assurance, with a focus on compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other relevant regulatory standards. The QA/QMS Analyst will assist in the maintenance and continual improvement of the QMS, ensuring that all documentation, including Standard Operating Procedures (SOPs), quality manuals, and other controlled documents, are created, revised, and archived appropriately. The role involves coordinating the implementation of change controls to ensure systematic evaluation and documentation of changes affecting the QMS. Additionally, the analyst will analyze quality data from various sources, including non-conformances, deviations, and Corrective and Preventive Actions (CAPAs), to identify trends and areas for improvement. Generating detailed reports on QMS performance metrics will be a key responsibility, providing insights and recommendations to senior management. The QA/QMS Analyst will also monitor key performance indicators (KPIs) related to quality, assist in planning and conducting internal audits, and support external audits conducted by regulatory agencies and clients. This includes preparing necessary documentation and providing responses to audit findings. Staying current with changes in regulatory requirements and industry standards is essential, as is conducting periodic reviews of QMS documentation and processes to verify ongoing compliance. The analyst will participate in risk assessments and contribute to the development of risk mitigation strategies within the QMS framework, identifying opportunities for improving quality processes and recommending enhancements to increase efficiency and effectiveness. Furthermore, the QA/QMS Analyst will lead or participate in root cause analysis for quality issues, ensuring that appropriate corrective and preventive actions are identified, implemented, and monitored for effectiveness. Providing training and support to staff on QMS processes, regulatory requirements, and quality improvement initiatives is also a critical aspect of this role. Collaboration with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, is necessary to ensure alignment on quality objectives and regulatory compliance. The analyst will communicate effectively with internal stakeholders to provide updates on QMS activities, audit results, and continuous improvement initiatives, ensuring that all quality standards are met before product release.

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

Requirements

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

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan
• Yearly bonus eligibility