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.

EDUCATION

• Bachelor’s degree in Chemistry, Mechanical Engineering or equivalent experience

WORK EXPERIENCE

• Minimum 6 years of experience in laboratory environment
• Minimum 1-3 years of personnel management or project management

PREFERRED KNOWLEDGE, SKILLS AND ABILITIES

• cGMP
• ISO and USP/EP compendia, Specifically ISO 11040, 11608, and USP 381, 382. Basic statistical understanding
• Understanding of CAD Design, 3D Printing, Minitab, Zwick, Instron or Solidworks/ Solidworks PDM
• Strong oral and written communication skills and attention to detail required
• Awareness to relevant Company policies as they are related to the position covered by this Job Description
• Experience with Instron, Zwick, Benchtop Assembly Instrumentation, Medical Device EDDO’s, and Method Development and Validation strategies
• 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

• Job-related activities that require a physical activity such as standing in laboratory environment
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)
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ESSENTIAL DUTIES AND RESPONSIBILITIES

• Supervise the day to day activities of the P&P team and act as mentor.
• Preparation and reporting of KPI’s
• Knowledge and understanding of the following P&P test techniques and capabilities:
• Sample/Device Performance testing (ISO 11040 and 11608, etc.), Compendial testing (USP 381 and382), Force analysis, CAD and 3D design, Lab Scale Filling and Assembly, Method development and validation
• Assist 2nd Shift, CCI and P&P Manager with management and allocation of resources and assignments
• Assure that analysts have been adequately trained for their role.
• Review and release final reporting to internal and external customers as it pertains to the group. Communicate updates for all projects timely
• Follow required cGMP regulations and assure compliance per internal QA procedures
• Supervise and approve laboratory quality investigations to support internal and external customers
• Manage the development and validation of numerous analytical techniques
• Implement continuous improvement/lean activities and events for the group
• Write, review, and approve documents (Investigations, Work Instructions, SOP’s, etc.)
• Support internal and external audits as required
• Hire new employees ensuring that their qualification and skills set fit with the needs of the individual role
• Independently drive projects from initiation through completion
• Lead communication with internal and external customers
• Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity
• Assure Safety procedures are followed and identify any safety risks with preventative action
• Maintain cognizance of current validation requirements.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Other duties as assigned

ADDITIONAL RESPONSIBILITIES

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems