This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.
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 chemical and/or 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 regular team 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 investigators/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.
- Communicates and consults with other staff when assessing, acquiring, or deploying new electronic document management systems to ensure smooth transition and minimal disruption.
- Establishes and implements policies regarding document storage, sharing, transmission and destruction.
- Collaborate with stakeholders to define document storage, naming conventions, and metadata standards.
- 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.
- Collaborate with other departments within West to ensure that document management processes are consistent across the company.
Additional Responsibilities
- Lead executive and technical parts of projects/ programs related to the implementation of new technologies.
- Guiding or 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
- Master's Degree in technical discipline preferred
Work Experience
- 5+ years of experience required
- 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 Instron, CT scanner, oscilloscope, power supply, multi-meter, Zwick, CAD, and microscopes preferred
Preferred Knowledge, Skills and Abilities
- 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).
- Basic knowledge in Project Management in order to effectively collaborate with the global project management organization.
- 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.
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
- Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
- Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
- If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
- The ability to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions as required.
- Handling of biohazard material and components. #LI-AP1 #LI-ONSITE
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.