Job Title: Associate Metrology Specialist

Job Description

In this role, you will be responsible for providing support for maintaining the instrument quality program, including the creation of validation documents. The Associate Metrology Specialist must work with Lab Operations, D&T, and Quality Assurance to ensure compliance with processes and procedures to reduce risk and improve compliance and productivity. A high degree of consistent dedication, flexibility, accuracy, sound judgment, and reliability is required.

Responsibilities

• Responsible for data review and instrument qualification review per GDP requirements.
• Input data into SAP (instrument calibration management system).
• Create and revise documentation 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.
• Collaborate with lab employees, onsite contractors, and outside vendors for repair and installation of lab equipment.
• Provide input and support to maintain project schedules and activities for new installation projects, including creating instrument validation plans and change controls.
• Write and conduct laboratory investigations and deviations.
• Write and review work instructions and procedures.
• Stay 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.
• Manage Metrology purchasing and inventory of consumable instrument parts, ensuring compliance with the approved supplier list.
• Exhibit regular, reliable, punctual, and predictable attendance.
• Perform other duties as assigned.

Essential Skills

• Minimum 1 year of technical data review experience in a cGMP laboratory.
• Minimum 2 years of experience in the cGMP pharmaceutical industry.
• Experience with instrument calibration management systems (SAP preferred).
• Understanding of cGMP environment.
• Experience with Quality Management Systems and good documentation practices.
• Strong analytical and problem-solving skills.
• Superior verbal and written communication skills.
• Understanding of regulatory guidelines such as Z540, ISO, and cGMP.

Additional Skills & Qualifications

• Bachelor's degree in a related area or Associate's degree with equivalent experience.

Work Environment

This position is office-based and requires being on-site 4 to 5 days a week at our Exton, PA office. Most weeks will involve 5 days on-site.