Quality Systems Specialist II
1 week ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.
Job Description:The Quality Systems Specialist II will play a critical role in our Petersburg, Virginia site, which serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Key Responsibilities:- Participate in and support the execution of our Deviations and Corrective Action and Preventative Action (CAPA) program.
- Organize, oversee, and perform investigational write-ups within the allotted time frame.
- Lead or participate in root cause analysis investigations as either investigator or Quality Assurance.
- Responsible for completion of Root Cause Analysis (RCA) and identification of corrective/preventative actions.
- Approve Deviation/CAPA records.
- Implement, track, trend, and analyze CAPA, Deviations, and Management Notifications. Summarize findings and recommendations for management and team awareness and/or present at Quality Council meetings.
- Work across functions to ensure on-time completion of Deviations and CAPA.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Lead or participate in Quality Risk Management and Data Governance Processes as needed.
- Lead training related to the investigation and CAPA system and root cause analysis tools.
- Participate in activities to support regulatory agency inspections.
- Promote a quality mindset and quality excellence approach to all activities.
- Maintain written procedures for Deviation and CAPA program.
- Act as site subject matter expert for the Deviation and CAPA program and investigation/CAPA electronic management system.
- Develop and maintain root cause analysis tools.
- Travel is limited but may occasionally be required.
- 8 years' experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education.
- Project management, organization, and execution skills are required.
- Ability to apply technical expertise to solve problems and issues.
- Participating in and leading activities that support regulatory agency inspections is required.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills, and share knowledge with others.
- Interact with other functions and be able to take ownership of and follow through on assigned projects.
- Experience with Veeva.
- Yellow belt certification.
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US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and high prices in the United States. Our team of healthcare and pharmaceutical industry leaders is committed to ensuring quality generic medications are accessible and affordable to everyone.Job Description:Quality Systems Specialist II...
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