Development and testing organization provides drug and medical device development services.
Instruments and Equipment
Exhibits in-depth knowledge of departmental tools and equipment.
Offers expert troubleshooting assistance to staff and collaborates with vendors to address complex technical issues.
Compiles investigation results and suggests corrective actions when necessary.
Training
Manages the prompt creation and completion of training materials and competency checklists.
Recognizes and utilizes internal expertise across departments and locations to maintain a consistent and standardized training approach.
Standard Operating Procedures (SOPs)
Prepares and revises SOPs to align with current processes and ensure regulatory compliance.
Works closely with cross-functional teams and other locations to ensure timely SOP implementation and address any obstacles.
Instrument/Equipment/Assay Validation
Manages validation activities for new assays and equipment, ensuring their timely execution and implementation.
May research, develop, validate, and maintain procedures within assigned areas, and recommend improvements to management when necessary.
Process Improvement
Evaluates current workflows and suggests innovative solutions to optimize processes.
Collaborates with internal and external teams to ensure effective implementation of changes.
Acts as a subject matter expert for departmental functions and may participate in company-wide initiatives like Six Sigma.
Audits and Compliance
• Supports client audit processes and responds to audit-related inquiries.
Subject Matter Expertise
Acts as a departmental expert in all trained workstations.
Serves as a key resource for staff, addressing technical questions and resolving issues.
Requirements:
Degree in biological, chemical, physical, agricultural or pharmaceutical sciences or similar.
Around 4 years experience in Safety, Immunology, Special Chemistry testing or similar.
English and Japanese language skills.