This position is a quality assurance compliance role which supports IntegraDose operations and production by ensuring that quality systems and manufacturing operations are compliant with the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act.
Collaborate with the Manufacturing Quality Assurance Program Manager to implement and maintain the IntegraDose quality management system (QMS).
Establish, implement, maintain, and manage quality management system (QMS) functions including; documentation control, change control, equipment management, environmental monitoring, auditing, root cause analysis, and CAPA.
Take ownership and accountability for the Document Control System by managing the DCO and CO logs, assigning and issuing equipment numbers. Update documents (SOPs, forms, etc.), perform final reviews and approvals. Manage document logs, current document access, and document archival.
Assume ownership and accountability for event investigations and CAPA management, including, managing investigations and CA/PA logs. Evaluate investigation summaries by providing feedback to investigators. Perform quality system event investigations and Root Cause Analysis (RCA). Determine/Develop CA/PA appropriate to address event. Review and approve final investigations and CA/PAs. Maintain event investigation and CAPA system for compliance, including monitoring open CAPAs for timely review/closure.
Develop, maintain, and implement a training program. Provide staff training on new processes as applicable, including cGMP and GDP.
Develop protocols and perform internal audits of IntegraDose activities. Evaluate audit results, generate reports, and develop CA/PA. Determine associated process/program updates needed and revise procedures.
Participate in product recalls and complaints as part of the quality assurance team. Assume responsibility for assigned events, managing overall process and required documentation.
Determine and approve CA/PA for events and support related implementation.
Partner with Production to ensure efficient and successful manufacturing and release of product.
Provide new product development support.
Support Purchasing/Supply Chain functions, by maintaining approved critical vendor lists and managing supplier performance evaluation through quality questionnaires.
Bachelors degree in Science, Microbiology, or Engineering or related field and/or 6 years of equivalent experience.
Documented training in cGMP quality system functions such as CAPA, RCA, Environmental Monitoring
5 years of progressive experience within cGMP quality operations and FDA regulated environments
1 2 years experience within a pharmaceutical laboratory or manufacturing environment providing familiarity with manufacturing process and operations, automation, equipment/facilities validation
2+ years experience within a quality role in an FDA regulated environment
Strong understanding of 21 CFR Part 210/211 requirements and knowledge of tools, concepts and methodologies of quality assurance and compliance systems, e.g. FDA, MN BOP, DEA
3 5 years experience within a pharmaceutical laboratory or manufacturing environment
2+ years experience within a 503B outsourcing facility and/or aseptic/parenteral manufacturing environment in a quality role
ASQ Certification in Quality Improvement Associate, or similar
ISO 9001 (or ISO 17025) Internal Auditor Certification
Together with the University of Minnesota and University of Minnesota Physicians we have created M Health Fairview. M Health Fairview is the newly expanded collaboration among the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine — expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
Fairview Health Services (fairview.org) is an award-winning, nonprofit health system providing exceptional care across the full spectrum of health care services. Fairview is one of the most comprehensive and geographically accessible systems in the state, with 10 hospitals—including an academic medical center and long-term care hospital—serving the greater Twin Cities metro area.
Its broad continuum also includes 60 primary care clinics, specialty clinics, senior living communities, retail and specialty pharmacies, pharmacy benefit management services, rehabilitation centers, counseling and home health care services, medical transportation, an integrated provider network and health insurer PreferredOne. In partnership ...with the University of Minnesota, Fairview’s 32,000 employees and 2,400 affiliated providers embrace innovation to drive a healthier future through healing, discovery and education.