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Quality Assurance and Quality Management Systems Specialist

2 months ago

Sacramento, California, United States Nivagen Pharmaceuticals Full time
Job Overview

Company Overview:

Nivagen Pharmaceuticals is a worldwide organization committed to improving lives through the development and provision of affordable generic medications and over-the-counter products tailored for the North American market. For over ten years, we have upheld our dedication to the principles of excellence, integrity, and respect for individuals. Our team of experts works diligently to drive innovations in manufacturing, distribution, and quality assurance, ensuring a comprehensive approach to healthcare. By integrating the pharmaceutical supply chain, leveraging advanced technology, and maintaining an unwavering commitment to quality, we aim to enhance medication accessibility and affordability. We prioritize our workforce's well-being by offering competitive salaries, extensive benefits, and strong training and development programs. By investing in our employees and nurturing a culture of growth and support, we empower our team to foster innovation and positively impact the healthcare sector. At Nivagen, our mission is to significantly improve lives by delivering high-quality, affordable medications while adhering to the highest standards of integrity and excellence.

Position Summary:

The QA/QMS Analyst will play a crucial role in supporting the establishment, execution, and upkeep of the Quality Management System (QMS) in alignment with regulatory mandates and industry benchmarks. This position entails evaluating quality data, overseeing documentation, coordinating audits, and spearheading continuous improvement efforts to guarantee the utmost standards of product quality and regulatory adherence within the pharmaceutical sector.

Key Responsibilities:

  • Support the enhancement and ongoing development of the QMS, ensuring adherence to GMP, FDA, EMA, and other pertinent regulatory standards.
  • Oversee QMS documentation, including the formulation, modification, and preservation of SOPs, quality manuals, and other controlled documents.
  • Facilitate the execution of change controls to ensure systematic assessment and documentation of changes impacting the QMS.
  • Evaluate quality data from diverse sources, including non-conformances, deviations, and CAPAs, to pinpoint trends and areas for enhancement.
  • Produce comprehensive reports on QMS performance metrics, offering insights and recommendations to senior management.
  • Monitor essential performance indicators (KPIs) related to quality, such as defect rates, audit outcomes, and CAPA completion timelines.
  • Assist in planning, executing, and documenting internal audits to ensure compliance with the QMS and regulatory standards.
  • Support external audits conducted by regulatory bodies and clients, preparing necessary documentation and addressing audit findings.
  • Track and follow up on audit findings to ensure timely and effective resolution, including the implementation of corrective and preventive actions.
  • Stay informed about 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 formulation of risk mitigation strategies within the QMS framework.
  • Identify opportunities for enhancing quality processes and the overall QMS, recommending and implementing improvements to boost efficiency and effectiveness.
  • Lead or engage in root cause analysis for quality issues, ensuring that appropriate corrective and preventive actions are identified, executed, and monitored for effectiveness.
  • Provide training and support to staff on QMS processes, regulatory requirements, and quality enhancement initiatives.
  • Collaborate closely with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, to ensure alignment on quality objectives and regulatory compliance.
  • Work 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 and Experience:

  • A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related fields 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, 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 be willing to relocate to the Sacramento Metropolitan Region.

Benefits:

  • Competitive salary range of $75,000-$85,000 per year.
  • Eligibility for yearly bonuses.
  • Comprehensive benefits package, including medical, dental, and vision coverage.
  • Paid time off plan.
  • 401k savings plan.

Additional Information:

Nivagen is committed to providing equal employment opportunities 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 status, gender identity, marital status, parental status, sexual orientation, veteran status, genetic information, or other factors prohibited by law, and to prohibiting harassment or retaliation based on any of these factors.

We are focused on building a diverse and inclusive workforce. If you are enthusiastic about this role but do not meet 100% of the qualifications listed above, we encourage you to apply.