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.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
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
- 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 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
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
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.
20%
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.
40%
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.
40%
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
- 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
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 lead development of validation strategy for projects, systems, and processes.
- Implement procedures, training and oversight to ensure the integrity of data generated to support testing processes.
- Manage contractors supporting validation projects
- 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 20% of the time may be required
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
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.
