CHEManager International · 1 day ago
Sr. Scientist - I
Exton, PA
Full-time
Hybrid
Senior Level
5+ years expWest is a dedicated team focused on improving patient lives through innovative healthcare solutions. In this role, you will assist engineers and scientists with laboratory tasks, conduct physical analyses, and ensure compliance with safety and quality standards.
Responsibilities
Oversees work for timely completion of a complaint investigation and response to the various customers
Communicates with customers regarding complaints, product issues and returned devices
Identifies critical product issues. Contacts appropriate support and/or management to ensure issues are reported and resolved. Assists with corrective action when necessary
Leads meetings to resolve any obstacles or issues and to align on priorities
Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations
Provides training of new analysts on the processes and use of laboratory equipment
Assists with the creation, review and approval of investigation reports
Creates a safe work environment through identifying and resolving potential safety hazards; maintaining a clean, neat, and safe work environment; and modeling safe laboratory best practices
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
Exhibits regular, reliable, punctual, and predictable attendance
Develop and maintain document control procedures and policies to ensure compliance with GMP regulations
Ensure all laboratory documents are properly stored, tracked and archived in accordance with applicable regulations and guidelines, and easily accessible to authorized personnel
Implementing processes and procedures to ensure on-time delivery of testing in compliance with cGMP, the relevant Regulatory Guidelines/Industry Standards and the relevant local and global Safety Guidelines
Evaluates existing document management systems and procedures to determine current effectiveness and efficiency; identifies and recommends improvements
Provide training and guidance to employees on document management policies and procedures
Provide support for all types of audits including regulatory, customer and quality system audits
Lead executive and technical parts of projects/ programs related to the implementation of new technologies
Technically supporting customer audits in the testing laboratory area
Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues
Always complies with the company's safety and quality policies, including proper handling of biohazard materials and components
Qualification
Required
Bachelor's Degree in technical discipline or equivalent experience required
Minimum 5 years of experience required
Proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations
Exhibits regular, reliable, punctual, and predictable attendance
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
Creates a safe work environment through identifying and resolving potential safety hazards; maintaining a clean, neat, and safe work environment; and modeling safe laboratory best practices
Develop and maintain document control procedures and policies to ensure compliance with GMP regulations
Ensure all laboratory documents are properly stored, tracked and archived in accordance with applicable regulations and guidelines, and easily accessible to authorized personnel
Implementing processes and procedures to ensure on-time delivery of testing in compliance with cGMP, the relevant Regulatory Guidelines/Industry Standards and the relevant local and global Safety Guidelines
Provide support for all types of audits including regulatory, customer and quality system audits
Always complies with the company's safety and quality policies, including proper handling of biohazard materials and components
Preferred
Master's Degree in technical discipline or equivalent experience preferred
Experience in leading and developing others preferred
Experience in conducting root cause investigations of field units preferred
Experience in laboratory test equipment operation and maintenance such as but not limited to HIAC light obscuration, Flowcam, and microscopes preferred
Demonstrated ability to prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables
Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal)
Ability to collaborate with and effectively work as part of a global team
Active contribution to the progress of global projects and motivation to achieve deliverables in time
Proficient use of MS Office applications and (desirable Minitab, SAP and Master Control)
Self-reliant, diligent, flexible (with working time to fulfill requirements of a global role)
Clear communication (fluent in written and verbal English required)
Background in medical device or pharmaceutical industry
Knowledge of lean manufacturing and operational excellence concepts
Able to comply with the company's safety policy at all times
Able to comply with the company's quality policy at all times
Benefits
Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
Generous Paid Time Off (PTO):Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion-where all voices are heard and respected in a supportive environment.
Recognition & Rewards:Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase