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Abbott · 2 days ago

CAPA Process Analyst

United States - Ohio - Columbus

Full-time

Onsite

Entry Level

$61K/yr - $123K/yr

2+ years exp

Abbott is a global healthcare leader that creates breakthrough science to improve people’s health. The CAPA Process Analyst role involves progressing investigations through the CAPA system, ensuring effective actions are implemented to address nonconformities, and maintaining audit-readiness of CAPA documentation.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, and/or deviations, as output from the division’s Quality System

Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance

Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area

EnsureS all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner

Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements

Supports the attainment of division goals and objectives

Accountable to the Quality Organization for achieving mutually agreed upon objectives

Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances

The CAPA System is a key inspection focus of worldwide regulators and auditors. The system must be usable, simple, sustainable and well maintained

Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls

Decisions and recommendations made by this position impact quality decisions for marketed products and the division’s Quality System

Qualification

FDA Quality System RegulationsISO13485Project ManagementInvestigational ToolsAttention to DetailWritten CommunicationOral CommunicationIndependent Work

Required

Minimum of two years of experience working in a regulated environment or experience performing investigations

Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted

Good project management skills to deliver an effective service in a timely manner

Attention to detail to ensure accuracy of work that forms part of the Quality System documentation

Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization

Able to work independently

Preferred

Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred

Benefits

Production areas that are clean, well-lit and temperature-controlled

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1

Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays

Retiree Healthcare program

Robust 401(k) retirement savings with a generous company match

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.