Quality Assurance QMS Lead-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 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: Quality Assurance QMS Lead-Parenteral (Full Time)

At Nivagen as Quality Assurance QMS Lead 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 analyzing 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 reoccurrence.
• 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 in a timely manner.
• 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 electronic Quality Management system (eQMS) across organization.

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
• A minimum of Three or More 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:

• Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations
• Proficiency in handling of electronic Quality Management systems (QMS)Experience in conducting root cause investigations, and execution of change management, investigating of deviation/non-conformance.
• Ability to communicate effectively with customers to carry out requirements.
• Ability to work under time pressure, exert good judgment in special situations, make decisions independently under minimum supervision, and problem solve.
• Ability to influence team interactions and lead initiatives.
• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Demonstrated ability to coordinate and prioritize multiple tasks.

Job Requirements:

• This 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
• Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs.
• Overtime and weekend work may be required.
• Individuals must be available via cell phone (on-call).
• Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)

 

Benefits:

• Pay range $75,000-$85,000 per Year / $35/hr. (for hourly basis)
• Relocation assistance available
• Annual bonus Eligibility (Based on yearly company and personal performance)
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan with No matching

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.