Quality Assurance QMS Specialist - Parenteral

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 the 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, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: Quality Assurance QMS Specialist - Parenteral 

At Nivagen as a Quality Assurance QMS Specialist - Parenteral, 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:

• Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA.
  •    Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system, and CAPA program.
  •    To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent recurrence.
  •    Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems.
  •    Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions.
  •    Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed promptly.
  •    Act as a site instructor for Change Control, Deviation Management, and CAPA courses.
  •    Coaches lead investigators on technical writing.
  •    Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures.
  •    Supports and initiates deviations, trends, or other technical investigations, as applicable.
  •    Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding.
  •    Works with the network deviation program mentor to benchmark and replicate best practices.
  •    Effective implementation of the electronic Quality Management system (eQMS) across organisations.

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-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 be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)

• Additional Information:

  • Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs.
  • Overtime and weekend work may be required.
  • The individual must be available via cell phone (on-call).

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.