The CAPA Sr. Associate will support nonconformance investigations, CAPA activities, root cause analysis, technical documentation, and effectiveness checks within a regulated pharmaceutical or medical device manufacturing environment.
Description:
- Execute and document nonconformance investigations, including identification of root, probable, potential, and contributing causes.
- Develop investigation strategies through multidisciplinary collaboration, process observations, product/sample evaluations, interviews, and follow-up activities.
- Prepare clear technical reports, including investigation plans, executive summaries, testing strategies, root cause hypotheses, and investigation results.
- Apply Root Cause Analysis tools and coordinate with SMEs to obtain scientific and technical input.
- Support identification and implementation of mitigation actions, Corrective and Preventive Actions, and Effectiveness Check criteria.
- Partner with Investigation and CAPA approvers to support timely execution and closure of records.
- Participate in CAPA review boards and continuous improvement initiatives.
- Provide coaching, mentoring, and guidance related to Nonconformance and CAPA processes.
- Promote compliance with applicable EHS practices and a zero-harm workplace.
Qualifications:
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum 5 years of experience in the pharmaceutical, drug manufacturing, or medical device industry.
- Minimum 3 years of experience in a similar role or responsibility; 5+ years preferred.
- Minimum 3 years of supervisory experience; 5+ years preferred.
- Strong knowledge of Quality Systems and Good Manufacturing Practices (GMP).
- TrackWise experience preferred.
- Strong analytical, problem-solving, leadership, communication, influencing, and negotiation skills.
- Fluent in written and spoken English.
- Bilingual English/Spanish.
- Ability to work effectively within multidisciplinary teams.
- Willingness to travel occasionally.
Physical Requirements
- Light work, including occasional lifting of up to 20 lbs and the ability to walk, stand, or perform other physical activities associated with a manufacturing environment.
