Bachelors degree in Life Sciences, Engineering, or a related field.
At least 3 years of experience in pharmaceutical manufacturing, preferably in packaging or aseptic filling environments.
Demonstrated experience managing or closing CAPAs within a regulated cGMP/FDA environment.
Strong understanding of deviation investigations, root cause analysis, and quality systems.
Previous pharmaceutical GMP experience with filling and packaging operations.
Hands-on CAPA closure experience, including verification of effectiveness and documentation of closure rationale.
Experience with investigations, including customer complaints and deviation-related root cause analysis.
Proficiency using electronic quality management systems, particularly TrackWise, and familiarity with other systems such as Veeva or MasterControl.
Review deviation investigations tied to packaging and filling processes to ensure accurate root cause identification.
Ability to review and update SOPs, batch records, and other technical documentation in a clear and compliant manner.
Strong attention to detail and ability to maintain accurate, audit-ready records.
Effective communication and collaboration skills for working with Quality Assurance, Manufacturing, Engineering, and Technical Writing teams.