Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Position Overview
The Quality Engineer, Metrology, is a role within the Quality Control (QC) organization which oversees the GMP analytical equipment/instrumentation for both Chemical Testing and Microbiology. The individual in this position will schedule, execute, review, and approve calibration and preventative maintenance (PM) for laboratory instrumentation and enter it into the maintenance database.
This role would be the Subject Matter Expert for the instrumentation for the Quality Control department, supporting training, troubleshooting, and determining best practices for QC equipment. The role also supports the Capital Appropriation Request process by working with the QC groups to identify the appropriate instrumentation, working with vendors to obtain quotes, and supports the onboarding process following procurement.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority
The incumbent in this position is specifically focused on Quality Control Laboratories and provides oversight of the calibration and preventative maintenance of equipment for the QC laboratory. The role will be responsible for scheduling, execution, and record management for the calibration and preventative maintenance of all QC software and equipment. Additionally, acts as a Subject Matter Expert for instrumentation topics.
Key Accountabilities
1. Calibration / Preventative Maintenance (60%)
Schedule and execute Calibration/PM on QC instruments
Schedule Vendor Support for Calibration/PM
Support Troubleshooting on QC instruments
2. Equipment/ Software Onboarding (20%)
Supports Capital Appropriation Request and Change Control Processes
Executes qualification/validation protocols on new instrumentation
Authors SOP requirements for Maintenance Activities
3. Data Integrity (20%)
Identify compliance and data integrity issues related to QC equipment and implement effective resolutions.
4. Safety
Follows EH&S procedures to ensure a safe work environment
Qualifications
Education & Experience
* Bachelor’s degree in life science, physical science, or technology field with 6+ years’ laboratory experience in QC functions in a GMP laboratory
* Direct experience executing calibration, preventative maintenance, troubleshooting, and repairs on laboratory equipment for both Chemical Testing and Microbiology
* Data Integrity assessment experience
* Excellent knowledge of FDA regulations, ISPE guidelines, and ISO standards
Knowledge
* Review and evaluate instrumentation for procurement by evaluating against compliance, regulations, and fit for purpose
* Execute protocols for the onboarding of new QC instrumentation, support and implement solutions for validation-related discrepancies and deviations
* Manage approved contractors/instrument vendors
* Execute, review, and approve calibration and preventative maintenance (PM) activities
* Document and maintain calibration and preventative maintenance activities in the Maintenance Management and Scheduling System
* Perform troubleshooting on QC instruments, resulting in performing repairs or coordination with external service contractors
* Conduct training on technical principles for QC Instrumentation
* Experience working in a GMP Quality Control Laboratory.
Skills & Abilities
* Work in compliance with Quality Management System requirements
* Intermediate to advanced computer skills
* Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines
* Experience with Customer interface and meeting customer expectations.
* Regularly contributes and represents department/group on multi-disciplinary teams. Builds extensive relationships across the organization and has an in-depth understanding of all key departments and how they interface with responsibilities.
* Coordinate with end users and process owners to identify QC instrumentation requirements to support procurement of new instrumentation
* Author and maintain procedures for the calibration and preventative maintenance of QC instrumentation
* Training and oversight to ensure the integrity of data generated to support testing processes.
* Manage contractors supporting calibration and preventative maintenance activities
* Work independently on assessment using knowledge and work experience. Gather input from colleagues and management to address issues.
Physical Requirements
* Ability to lift 15 lbs.
* Ability to walk across plant/laboratory
* Travel up to 10% of the time may be required
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
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