Sr. Scientist - I

 

This is an onsite position requiring the team member to be onsite 5 days a week

 

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

• In this role, you will assist engineers and scientists with a variety of laboratory tasks. This includes performing physical analyses or scientific tests using both routine and special techniques in compliance with all safety, infection control standards and - in case of computerized systems data integrity requirements.
• You will collect, analyze and process laboratory samples, record results of tests, organize data, and prepare reports and analyses using standard procedures and guidelines.

Essential Duties and 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.

Additional Responsibilities

• 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.

Education

• Bachelor's Degree in technical discipline or equivalent experience required or
• Master's Degree in technical discipline or equivalent experience preferred

Work Experience

• Minimum 5 years of experience required
• Experience in leading and developing others preferred
• Experience in c