Lead Deviation Investigations to Ensure Product Quality and Patient Safety
Support production and quality assurance activities in North Carolina by leading deviation investigations that make a real difference in pharmaceutical manufacturing. This role focuses on investigating deviations, performing quick containment actions, and conducting root cause analyses to address issues effectively.
Primary Responsibilities
- Investigate deviations and perform root cause analyses to address issues effectively.
- Implement quick containment actions to mitigate potential risks.
- Ensure compliance with relevant standards and guidelines.
- Identify and recommend process improvement opportunities for routine to moderately complex issues.
- Conduct process confirmations and review batch production records (BPRs) as needed.
- Follow all safety and environmental protocols.
- Perform other duties as assigned.
Skills and Requirements
- Associate degree in technology, engineering technology, or a related field from an accredited institution, or a high school diploma/equivalent with at least two years of manufacturing experience.
- Preferred experience includes at least one year in a pharmaceutical manufacturing environment, deviation investigation, or quality assurance.
- Knowledge of Good Manufacturing Practices (GMP) and related systems is highly desirable.
- Strong written communication skills and systematic problem-solving abilities.
- Ability to work effectively in an open office environment with potential distractions.