CAPA Process Analyst at Abbott Laboratories

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

The Opportunity

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of CAPA Process Analyst is within our CMI Business Unit.  This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control.  This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Determine quality attributes and requirements. May provide technical assistance.
• Independently contribute to Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Independently utilize quality management techniques to perform investigations and facilitate solutions.
• Responsible for independently completing documentation in a timely manner and in accordance with business standards.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations.
• Provide support to QA activities for regulatory compliance, (i.e. Management Review support, regulatory audits).
• May assist in the training of personnel as directed by management.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• Work with managers to coordinate training requirements for employees as required.
• Manage training program and organizational chart as required.
• Review/approve supplier surveys and make recommendations as required.
• Assist with internal audits and agency audits.
• Manage Document Control as required.
• Manage equipment maintenance and calibration program as required.
• Assist with equipment, process and facility qualification and validation activities as required.
• Review Raw Material Specification QC Forms.
• Mentor and train junior level associates.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Carries out duties in compliance with established business policies
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Perform other duties and projects as assigned.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience.
• Minimum of two years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 1-3 years of progressively responsible positions.
• Minimum of 2 years of experience in assigned subsystem(s).
• Strong writing and verbal communication skills.
• Must be detail-orientated, self-motivated and available for flexible scheduling.
• Proficient with Microsoft Office, including Word, Excel and PowerPoint and Visio.

PREFERRED QUALIFICATIONS:

• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR.
• Direct experience with 21 CFR 820, ISO 13485.
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
• Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures.
• Ability or aptitude to work on problems of moderate scope.
• Goal oriented, learns quickly, works in a collaborative manner with other departments.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize;  strong organizational and project management skills.
• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.