Beschreibung

In this role, you will support engineers and scientists by performing laboratory analyses, managing complaint investigations, and ensuring compliance with safety and quality standards. Your daily responsibilities will include training new team members, maintaining document control, and collaborating with various departments to enhance laboratory processes.

Anforderungen

• •Bachelor's Degree in technical discipline or equivalent experience
• •Master's Degree in technical discipline
• •5+ years of experience
• •Experience in leading and developing others
• •Experience in conducting root cause investigations
• •Experience in laboratory test equipment operation and maintenance
• •Effective time management skills
• •Ability to communicate technical ideas with diverse audiences
• •Ability to collaborate with a global team
• •Active contribution to global projects
• •Proficient use of MS Office applications
• •Basic knowledge in Project Management
• •Fluent in written and verbal English
• •Background in medical device or pharmaceutical industry
• •Knowledge of lean manufacturing concepts
• •Compliance with safety policy
• •Compliance with quality policy
• •Ability to lift and carry items up to 50 pounds
• •Handling of biohazard material

Aufgaben

• •Assist engineers and scientists with laboratory tasks
• •Perform chemical and physical analyses using routine and special techniques
• •Collect, analyze, and process laboratory samples
• •Record test results and organize data
• •Prepare reports and analyses following standard procedures
• •Oversee timely completion of complaint investigations
• •Communicate with customers about complaints and product issues
• •Identify critical product issues and report them to management
• •Assist with corrective actions when necessary
• •Lead regular team meetings to resolve obstacles and align priorities
• •Maintain and use laboratory test equipment for root-cause investigations
• •Train new investigators and analysts on processes and equipment
• •Assist in creating, reviewing, and approving investigation reports
• •Ensure a safe work environment by identifying and resolving hazards
• •Maintain compliance with regulations, policies, and safety rules
• •Exhibit reliable and punctual attendance
• •Develop and maintain document control procedures for GMP compliance
• •Ensure proper storage, tracking, and archiving of laboratory documents
• •Implement processes for on-time delivery of testing in compliance with cGMP
• •Evaluate and recommend improvements to document management systems
• •Consult with staff on new electronic document management systems
• •Establish policies for document storage, sharing, and destruction
• •Collaborate with stakeholders on document management standards
• •Provide training on document management policies and procedures
• •Support audits including regulatory, customer, and quality system audits
• •Collaborate with departments to ensure consistent document management
• •Lead projects related to the implementation of new technologies
• •Guide customer audits in the testing laboratory area
• •Stay updated on best practices in document management technologies
• •Comply with safety and quality policies regarding biohazard materials

Tools & Technologien