CAPA Specialist II

Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

Responsibilities:
- Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
- Coordinates the exception document process and creates exception documents
- Independently leads complex, high impact investigations
- Ensures all investigations are written according to corporate and site requirements
- Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
- Ensures all Quality CAPA goals and metrics are met
- Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
- Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant

Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering
- 6+ years of experience in the pharmaceutical industry in Manufacturing, Quality, or Engineering
- Ability to problem solve and utilize analytical skills
- Knowledge of Quality/Compliance management, Regulations and Standards

Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
- Eligible to participate in short-term incentive programs