Science and Compliance Specialist, 3rd Shift

Must have knowledge of GMPs and worldwide regulatory agency guidelines.

Knowledge of applicable CAPA procedures, specifications, regulations and standards

Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data

Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)

Ability to utilize enterprise software systems (Veeva)

Ability to gown in C/D gowning area

Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.

Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools

Investigate the root cause(s) of the issue and document the investigation results

Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle

Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness

Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines