Manufacturing Quality Assurance CAPA Specialist

Fairview Health Services•Shoreview, MN

About The Position

This position is a quality assurance compliance role which supports the Fairview 503B manufacturing pharmacy, IntegraDose, in its operations and production by ensuring that the non-conformance and corrective and preventative action (CAPA) quality systems are compliant with the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act. This position collaborates with the Manufacturing Quality Assurance Program Manager to implement and maintain the IntegraDose quality management system (QMS).

Requirements

Bachelor’s 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
Experience with using MasterControl Software Suite for document control and training

Nice To Haves

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
MasterControl administration experience
Intermediate to advanced Microsoft Word, Excel, and MiniTab experience
ASQ Certification in Quality Improvement Associate, or similar
ISO 9001 (or ISO 17025) Internal Auditor Certification

Responsibilities

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 CAPA’s. Maintain event investigation and CAPA system for compliance, including monitoring open CAPA’s 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.