Metrology Specialist

IntePros is currently looking for a Metrology Specialist to join one of our growing medical device manufacturing clients in Exton, PA. The Metrology Specialist 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, IT and Quality Assurance to assure compliance with processes and procedures to reduce risk and improve compliance and productivity.

Metrology Specialist Responsibilities

• Create electronic instrument equipment validation plans in the tracking and approval systems.
• Responsible for creation of documentation and revisions of documents to support and maintain the quality management system for laboratory instruments
• Provide input and support to maintain the project schedules and activities for new instrument installation projects.
• Review and manage instrument repair documents for compliance to work instructions
• Support all types of audits including regulatory, customer and quality management system
• Write installation qualification (IQ) documents, operational qualification (OQ) and process qualification (PQ) validation documents for new laboratory instruments purchases. Examples include chromatography, instruments, UVs and various other analytical instruments.
• Write documents such as laboratory investigations, work instructions, and procedures
• Provide updates to weekly instrument meetings on status of documents and activities
• Responsible for data input into SAP equipment, calibration and maintenance module
• Develop all key validation documents using functional, user requirements, design specifications, equipment manuals and risk assessments for fully compliant GMP 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
• 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
• Other duties as assigned
  
  

Metrology Specialist Basic Qualifications

• Bachelor’s of Science degree in a related area
• 3 years of documentation and validation experience in the pharmaceutical industry
• List any required certifications
  
  

Metrology Specialist Preferred Knowledge, Skills And Abilities

• Strong understanding of a cGMP environment
• Experience with Quality Management Systems and good documentation practices
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  
  

Travel Requirements

• Minimal travel required
  
  

Physical & Mental Requirements

• Employee may be required to lift objects (up to 25 lbs) without assistance
• Must be able to multi-task, work under time constraints, problem solve and prioritize
• Use written and oral communication skills
• Learn and apply new information and new skills
• Work under deadlines with constant interruptions
• Must maintain the ability to work well with others in a variety of situations