What are the responsibilities and job description for the Senior Quality Control Engineer – Metrology and Calibration position at Endo?
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.
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.
Additionally, this role would be the Subject Matter Expert for the instrumentation for the Quality Control department, supporting training, troubleshooting and determining best practice 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 - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.
The incumbent in this position is specifically to focus 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 - key outcomes/deliverables, the major responsibilities, and % of time
Calibration / Preventative Maintenance
Schedule and execute Calibration/PM on QC instruments
Schedule Vendors Support for Calibration/PM
Support Troubleshooting on QC instruments
60%
Equipment/ Software Onboarding
Supports Capital Appropriation Request and Change Control Processes
Executes qualification/validation protocols on new instrumentation
Authors SOP requirements for Maintenance Activities
20%
Data Integrity
Identify compliance and data integrity issues related to QC equipment and implement effective resolutions.
20%
Safety
Follows EH&S procedures to ensure a safe work environment
Continuous
Other
Customer interface and meeting customer expectations
-
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- 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
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- 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
- Manages 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
- Performs troubleshooting on QC instruments, resulting in performing repairs or coordination with external service contractors
- Conducts training on technical principles for QC Instrumentation
- Experience working in a GMP Quality Control Laboratory.
Skills & Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- 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 department 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
- Works independently on assessment using knowledge and work experience. Gathers input from colleagues and management to address issues.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- 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.
