CAPA Specialist, Microbiology - Sturgis, MI Plant

Abbott • Sturgis, MI

83d • $60,000 - $120,000

About The Position

The CAPA Specialist progresses investigations through the CAPA system. Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems. Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers and that required standards and/or procedural requirements are met. Be an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct. Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from ADC’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 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. You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Requirements

• High school diploma / GED AND 2 years CAPA work experience in manufacturing plant environment OR Associate's degree.
• Minimum 2 years’ experience in a regulated manufacturing environment.
• Ability to apply strategic and quality logic and project management skills to investigation activities.
• Good project management skills to deliver effective service in a timely manner.
• Attention to detail to ensure accuracy of work forming part of the Quality System documentation.
• Good written and oral communication skills.

Nice To Haves

• Knowledge of FDA Quality System Regulations.

Responsibilities

• Progress investigations through the CAPA system.
• Work closely with other functional areas using investigational tools to determine root causes of nonconformities.
• Ensure CAPA plans address root causes and that corrective and preventative actions are implemented.
• Evaluate and progress the timely completion of CAPA system activities.
• Facilitate the investigation process to ensure appropriate root/potential causes are identified.
• Maintain effectiveness of CAPA system records for audit-readiness.
• Manage CAPA-related documentation in a clear and controlled manner.
• Support a work environment that ensures team effectiveness.
• Support other organizations in managing their CAPA actions.

Benefits

• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement and FreeU education benefit.
• Career development opportunities.
• Recognition as a great place to work in multiple countries.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees