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 instrumentsProvide 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 instructionsSupport all types of audits including regulatory, customer and quality management systemWrite 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 proceduresProvide updates to weekly instrument meetings on status of documents and activitiesResponsible for data input into SAP equipment, calibration and maintenance moduleDevelop 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 managementSupport and collaborate with lab employees, onsite contractors and outside vendors for repair and installation of lab equipmentMust keep current with new technologies and cGMP regulationsSupport the Lab Metrology group with other activities and projects as neededPerform follow-up activities for metrology area of workOther 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 industryList any required certifications Metrology Specialist Preferred Knowledge, Skills and Abilities:Strong understanding of a cGMP environmentExperience with Quality Management Systems and good documentation practicesAble 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 requiredPhysical & Mental Requirements:Employee may be required to lift objects (up to 25 lbs) without assistanceMust be able to multi-task, work under time constraints, problem solve and prioritizeUse written and oral communication skillsLearn and apply new information and new skillsWork under deadlines with constant interruptionsMust maintain the ability to work well with others in a variety of situations

Created: 2024-11-02