Sr Quality Control Engineer

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.

Job Description Summary

The Quality Engineer is a role within the Quality Control organization which oversees Computer System Validation (CSV) activities for all Quality Control software and equipment/instrumentation. The individual in this position will create, execute, review, and approve validation documentation, participate in cross-functional planning, and execution meetings as well as provide support for issue resolution.

Additionally, this role would be the Subject Matter Expert for Data Integrity for the Quality Control department. The role is responsible for identifying compliance and data integrity issues related to QC equipment and implement effective resolutions. The role provides assistance to Regulatory Agency inspections and audits in addition to providing guidance and recommendations for identified data situations.

Job Description

Scope of Authority

The incumbent in this position is specifically to focus Quality Control Laboratories and provides software/equipment/process solutions to the laboratory. The role will be responsible for creation, execution, and approval of validation for all QC software and equipment.    Additionally, acts as a Subject Matter Expert for electronic Data Integrity topics.

Key Accountabilities

Accountability

Project Planning

Develop, manage, and oversee validation plans.

Define project timelines and provide updates to stakeholders.

Create and manage Capital Appropriation Requests.

Highlight, communicate and elevate issues as needed.

Equipment/ Software Onboarding

Oversee site validation activities (e.g., equipment, processes, computer system validation) to ensure compliance with cGMP.

Lifecycle management of Quality Control software and equipment.

Data Integrity

Identify compliance and data integrity issues related to QC equipment and implement effective resolutions.

Participate on management teams preparing for audits and inspections.

Safety

Follows EH&S procedures to ensure a safe work environment

Continuous

Other

Customer interface and meeting customer expectations

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
• Data Integrity assessment experience
• Direct experience authoring/editing/executing validation documents for laboratory equipment and/or laboratory systems (LIMS, ELN, CDS)
• 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 internal validation documentation (i.e., user requirement specifications, functional specifications, protocols, reports, etc.)
• Perform review of vendor protocols and creation of in-house supporting documentation to deliver a complete package of qualification documentation
• Develop and implement solutions to validation related discrepancies and deviations
• Ensure compliance to data integrity requirements in a GMP environment
• Computer System Validation (CSV) experience within the life sciences industry.
• 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 department and how they interface with responsibilities.
• Coordinate with end users and process owners to lead development of validation strategy for projects,