West Pharma Metrology Specialist 

United States, Pennsylvania, West Whiteland Township 

420158939

In this role, you will be responsible for providing support for maintaining the instrument quality program including the creation of validation documents. The Specialist must work with Lab Operations, D&T, and Quality Assurance to assure compliance with processes and procedures to reduce risk and improve compliance and productivity.

• Responsible for data review and instrument qualification review per GDP requirements.
• Responsible for data input into SAP (instrument calibration management system)
• Responsible for creation of documentation and revisions of documents to support and maintain the quality management system for laboratory instruments.
• Support and maintain the instrument quality program including annual installation qualifications, preventative maintenance documentation, and instrument asset life cycle management.
• Support and collaborate with lab employees, onsite contractors and outside vendors for repair and installation of lab equipment
• Provide input and support to maintain the project schedules and activities for new installation projects. This includes creating instrument validation plans and change controls for new installation
• Writing and conducting laboratory investigations and deviations
• Writing and reviewing work instructions and procedures
• Must keep current with new technologies and cGMP regulations
• Support the lab Metrology group with other activities and projects as needed.
• Perform follow-up activities for metrology area of work
• Responsible for Metrology purchasing and inventory of consumable instrument parts, and assuring compliance with the approved supplier list
• Other duties as assigned

• Bachelor’s of Science degree in related area or Associates with equivalent experience

• Minimum 2 years of technical data review experience in cGMP laboratory
• Minimum 3 years’ experience in cGMP pharmaceutical industry

• Strong understanding of a cGMP environment
• Experience with Quality Management Systems and good documentation practices
• Basic analytical instrumentation troubleshooting skills
• Excellent problem-solving skills and root cause analysis
• Understanding of regulatory guidelines such as Z540, ISO 9001, ISO 17025 and cGMP
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• 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, prioritize and work under deadlines with constant interruptions
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes.
• Learn and apply new information and new skills