Description: 

Investigating nonconforming events, developing CAPAs, root cause analysis, drafting documents, coordinating processes, and driving approval and resolution as part of the Operations Compliance Team. 

Job Responsibilities: 

• Performs and documents GMP root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for manufacturing and packaging. 
• Driving the event investigation down to the root cause, suggest corrective actions,?and document findings. 
• Develops, documents, and tracks to completion of corrective and preventive actions (CAPA) to prevent nonconformities from occurring again. 
• Performs other compliance related tasks to support the business, such as authoring change requests to operating procedures, providing support for internal and customer audits and reviewing logbooks, batch records, etc. for accuracy and completeness. 
• Holds regular review meetings and monitors tasks to ensure timely completion. 
• Ensure that all investigations are written according to corporate, division, and local requirements. 
• Responsible for consistent and thorough exception of documents and timely resolution of investigations based on CAPA requirements. 
• Coordinate the exception document process and write exception documents. 
• Work as individual contributor mostly; expected to lead own investigation cases. 
• Working in GMP regulated production area performing exception reporting/investigation 

Qualifications: 

• Preferably a BS in Chemistry, Biology, Engineering Pharmacy, or Microbiology with minimum of 5+ years of experience in Quality Assurance or Pharmaceutical Manufacturing such as regulated GxP environment in qualification / validation, documentation, operations, or compliance.  
• Sound knowledge of the current regulatory requirements (21 CFR Part 11, EU GMP Annex 11 / 15, ICH, PIC/S) and Best Practices (GAMP5, etc.).   

Requested experience: 

• Extensive technical writing capability for nonconformances and investigations. 
• Prefer previous experience in GMP manufacturing or quality settings. 
• Must have CAPA experience.