Scientific Investigator - Biochemistry

Full Job Description

Job Description

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 ActionPreventive Actions (CAPA) to minimize repeat errors.

Proficiently utilizes all laboratory systems such as laboratory information systems (LIMS) 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 investigations 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