Scientist, Quality - CAPA

Job Description Summary:

The Scientist, Quality - CAPA supports corrective and preventive action activities within the Quality Team as part of an End-to-End (E2E) Laboratory Modernization Program. This role is responsible for coordinating investigations, managing deviations and non-conformances, facilitating root cause analyses, and ensuring corrective and preventive actions are implemented effectively and in a timely manner. The level of responsibility, autonomy, and technical complexity will be commensurate with experience and qualifications.

Job Responsibilities

• Coordinate and manage CAPA activities associated with laboratory deviations, non-conformances, audit findings, and customer observations.
• Lead or support investigations and root cause analyses using established quality methodologies.
• Track CAPA records and monitor action items to ensure timely completion and effectiveness.
• Facilitate cross-functional discussions involving laboratory personnel, quality representatives, and stakeholders.
• Support deviation management, effectiveness checks, and continuous improvement activities.
• Review documentation for completeness, accuracy, and compliance with quality requirements.
• Support internal audits, inspection readiness, and regulatory compliance activities.
• Identify opportunities to improve quality systems and streamline processes.
• Maintain training and compliance in health, safety, environmental, and operational requirements.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Strong understanding of CAPA principles, deviation management, and root cause analysis techniques.
• Knowledge of ISO 17025 quality systems and regulatory requirements.
• Excellent analytical, organizational, and problem-solving skills.
• Strong technical writing and documentation review capabilities.
• Effective communication and collaboration skills.

Basic Qualifications:

• Bachelor's degree in chemistry, biology, or related scientific discipline.
• OR Associate degree with 2+ years of relevant quality or laboratory experience.
• Relevant quality-related laboratory experience commensurate with level (entry-level candidates through experienced scientists will be considered).
• Demonstrated ability to work both independently and collaboratively in a regulated laboratory environment.
• Adaptable, self-motivated, and capable of managing tasks with strong attention to detail.

Preferred Qualifications:

• Experience managing CAPA systems and non-conformance investigations.
• Experience with root cause analysis tools and continuous improvement methodologies.
• Experience within ISO 17025, GLP, GMP, or FDA-regulated environments.
• Familiarity with quality management systems and electronic documentation platforms.

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite. Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.