Nivagen Pharmaceuticals, Inc.
Job Title
QA Specialist Company
Nivagen Pharmaceuticals, Inc. Location
Nivagen Pharmaceuticals Inc., 3900 Duckhorn Drive, Sacramento, CA 95834 (Sacramento Metropolitan Region) About the Job
As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. 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. Drive root cause investigations and ensure assignment of corrective and preventive actions to eliminate root causes and prevent recurrence. Create and maintain the CAPA program through cross-functional collaboration with area/function owners. Compile and present CAPA program health metrics with proposed actions. Monitor deviation and CAPA performance to ensure investigations and CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coach lead investigators on technical writing. Author periodic reviews and act as Subject Matter Expert for site CAPA and Deviation Management procedures. Support and initiate deviations, trends, or other technical investigations, as applicable. Engage site personnel in the relationship between the CAPA program and resulting product and process improvements. Ensure effective implementation of electronic Quality Management System (eQMS) across the organization. Performs additional duties as assigned by the reporting manager. Qualifications
Education/Experience
Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1–3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities
Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements
Legally authorized to be employed in the United States Must live or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles radius) Benefits
Pay range $25.00 per hour to an annual salary of $70,000 Yearly bonus eligibility Medical, dental, and vision coverage Paid time off 401k savings plan Equal Opportunity
Nivagen provides equal employment opportunities to all individuals regardless of race, color, age, national origin, disability, or other protected characteristics, in accordance with applicable law.
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QA Specialist Company
Nivagen Pharmaceuticals, Inc. Location
Nivagen Pharmaceuticals Inc., 3900 Duckhorn Drive, Sacramento, CA 95834 (Sacramento Metropolitan Region) About the Job
As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. 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. Drive root cause investigations and ensure assignment of corrective and preventive actions to eliminate root causes and prevent recurrence. Create and maintain the CAPA program through cross-functional collaboration with area/function owners. Compile and present CAPA program health metrics with proposed actions. Monitor deviation and CAPA performance to ensure investigations and CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coach lead investigators on technical writing. Author periodic reviews and act as Subject Matter Expert for site CAPA and Deviation Management procedures. Support and initiate deviations, trends, or other technical investigations, as applicable. Engage site personnel in the relationship between the CAPA program and resulting product and process improvements. Ensure effective implementation of electronic Quality Management System (eQMS) across the organization. Performs additional duties as assigned by the reporting manager. Qualifications
Education/Experience
Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1–3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities
Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements
Legally authorized to be employed in the United States Must live or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles radius) Benefits
Pay range $25.00 per hour to an annual salary of $70,000 Yearly bonus eligibility Medical, dental, and vision coverage Paid time off 401k savings plan Equal Opportunity
Nivagen provides equal employment opportunities to all individuals regardless of race, color, age, national origin, disability, or other protected characteristics, in accordance with applicable law.
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