Investigation Writer

About the role

Kelly Science, Engineering, Technology & Telecom is seeking an Investigation Writer to work with one of its top global biopharmaceutical clients in the Barceloneta PR area. The role provides quality assurance support for the plant, including event investigations and resolution, corrective and preventive action, local change plan coordination, complaint investigations, quality improvement programs, and assurance of cGMP and Customer policy compliance. The role also requires understanding internal business processes to prioritize assigned work duties.

Responsibilities

• Perform exception reports, complaints, PQRs, CP coordination, and trend monitoring, ensuring compliance with Customer Operations policies, plant procedures, and regulations.
• Investigate exception events in manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability, or complaints areas.
• Conduct thorough exception event investigations, document findings, and resolve exception documents in a timely manner based on CAPA requirements.
• Perform complaint investigations when product quality complaints are received at the plant, in compliance with Customer Operations policies, plant procedures, and regulatory requirements.
• Perform laboratory investigations when out-of-specification or trend results are reported, in accordance with Customer procedures and policies.
• Support plant users of the Expectation Events IT Systems.
• Document and coordinate Local change plan assessments and strategies with end users and impacted functional areas.
• Provide periodic quality metrics related to investigations.

Datos clave

• The role is in the Barceloneta PR area.
• The position provides quality assurance support for the plant.
• Responsibilities include investigations of exception events, complaints, and laboratory results.