Reporting directly to the Manager, Quality Systems & Compliance (QSC), this role is the CAPA coordinator for the site. This role is also responsible for performing routine Quality System tasks as assigned and for leading/executing various Quality System improvement projects.
SAFETY: Demonstrate safety performance behaviors and engage actively to promote.
COMPLIANCE: Manages CAPA related activities to ensure timely closure and effective plans. Supports regulatory and third party inspections for the site and acts as an audit host when necessary. Interfaces with outside regulatory and legal authorities as appropriate. Writes, reviews, revises and approves procedures and specifications, as needed. Provides oversight for various quality system elements and tools. Works with quality, operations, and above site regulatory and quality functions to ensure sound and timely decisions/investigations are documented regarding nonconformances, root cause and CAPA analysis. Acts as a liaison between retail customers and operations / quality.
MANAGING, PLANNING & DIRECTING: Manages the CAPA system and runs the CAPA board. Promotes open communications within the site and with external contacts. Leads and executes various projects to enhance the site’s quality systems. Reviews and issues final quality approval for CAPA plans and completed CAPA's. Escalates issues related to the effectiveness of the quality system where necessary.
CONTINUOUS IMPROVEMENT: Takes action to continually improve quality documentation and investigations based on tracking / trending activities. Enhances knowledge within the organization through training. Writes and reviews SOPs with a focus on improved content. Contributes to QPI improvement activities.
Scope of Position:
Reporting directly to the Manager, Quality Systems & Compliance (QSC), this role is responsible to perform routine Quality System tasks as assigned and lead/execute various Quality System improvement projects. This role works in the areas of documentation systems, NC/CAPA administration, nonconformance investigations, compliance, internal and supplier audits, and provides support for regulatory and other external audits. This role is responsible for achieving site level performance metrics within the scope of the position. This position is also the Quality contact for various retail customer related projects and backs up the QSC Manager on external audit management.
Internal customers include all departments within the organization.
External partners include regional / global quality counterparts, regulatory bodies, independent auditors, and customers.
Minimum of a B.S. degree, scientific discipline preferred
Specialized training in 21 CFR 211, 21 CFR 820, ISO 13485, MDSAP, and/or MDD/MDR is preferred.
Minimum of 5 years’ experience in a Quality Assurance role within an FDA regulated manufacturing or distribution facility required. Preferred experience is within a drug and/or device facility.
Experience authoring or reviewing CAPA's or investigations is required.
Experience in database applications (e.g. Excel, Access) required. Experience in quality system databases (D2, CQMS) preferred.
Skills: Demonstrated technical writing ability.
Strong organizational and communication skills required in order to develop programs. Ability to work independently with minimal supervision and effectively interact with all levels of the organization, including customers. Excellent time management skills. Six Sigma, Lean, and SPC training are preferred.