Job Abstract

A Biochemistry Senior Investigator is responsible for: conduction, and writing of complex GMP laboratory investigations; collaborating with technical and support staff to write, author and assist in implementation of effective Corrective Action/Preventive Actions (CAPA); support management by assisting and addressing internal and external audits; utilize all laboratory systems to accomplish these tasks.

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Applies the highest quality standard in all areas of responsibility
• Demonstrates and promotes the company vision
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Regular attendance and punctuality
• Assists Biochemistry Management with complex GMP laboratory investigations such as Out of Specifications, Out of Trend and Client Complaints.
• Independently initiate, conduct, write and complete routine investigations in a timely manner.
• Works closely with QA to ensure compliance to GMP requirements.
• Executes human error analysis.
• Collaborates with Laboratory Staff, and Biochemistry Operations to develop sustainable process improvements within the Biochemistry Department.
• Complete and implement effective Corrective Action\Preventive Actions (CAPA) to minimize repeat errors.
• Proficiently utlizes all laboratory systems such as laboratory information systems (eLIMS) and data collection systems such as Empower.
• Assist management with internal audits and laboratory walk through findings.
• Assist management in hosting client audits.
• Managing documentation in support of routine invesigations and corrective action follow up.
• Communicates effectively with client staff members
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned