Principal Quality Control Engineer, Chromatography

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

This Principal Quality Control Engineer, Chromatography, role provides oversight to the Chromatography programs for the global Quality Control (QC) organization.
This role acts as a business process architect for the Global Chromatography program, from analyst to training to software workflows. This role imagines, builds and implements workflows and policies for Chromatography systems and integrated systems across the Quality Control organization. The role supports the creation, implementation and administration of the Chromatography analyst and data reviewer qualification program. Additionally, the role supports the day-to-day activities required for the system, which includes building Empower objects, developing training modules, interacting with laboratory personnel, and coordinating the roll out of Empower updates. The oversight also includes supporting change management and validation activities impacting Chromatography testing or systems.
The ideal candidate has significant experience and in-depth understanding of the end-to-end science and compliance requirements for Chromatography testing in a regulated cGMP environment. The candidate will be fluent in compliant Chromatographic data acquisition, troubleshooting, processing, and integration.
All incumbents are responsible for following applicable Division & Company policies and procedures.

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 on the Global Quality Control Laboratories and provides Chromatography software/equipment/process solutions to the laboratories. The role will be responsible for the administration of Chromatography certification programs.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Program Administration

Ÿ Create, maintain and support the business process for the global CDS system with focus on optimized implementation of Empower functionality

Ÿ Act as SME for chromatography to support Chemists and Scientists

Ÿ System auditing, user support, & program management

Ÿ Performs other Chromatography-Related responsibilities, as assigned

50%

Project Management

• Manages coordination of Empower software updates and workflow configuration

• Supports change management and validation activities

• Support initiatives to drive Global harmonization of Chromatography practices and data management

30%

Training

• Create, implement, and administer the Chromatography analyst and data reviewer qualification program; perform certification review as required

• Create and manage train-the-trainer curriculum for Chromatography techniques.

• Monitors industry trends to identify training opportunities

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 7+ years’ laboratory experience in QC functions in a GMP laboratory

• Advanced experience with Waters Empower including data acquisition, report method and custom field building

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.

• Knowledge and understanding of quality processes, as well as cGMPs, SOPs and regulatory requirements.

• Strong computer/systems skills using Quality Management Systems, MS Office Suite, and/or Enterprise Resource tools (i.e., TrackWise, ComplianceWire, Veeva or similar).

• Strong technical writing and presentation skills.

• Continuous Improvement strategies such as Six Sigma

• Experience with Computer Software Validation

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.

• Strong attention to detail, be highly productive, and able to manage time and prioritize tasks to meet timelines

• Develop new concepts, techniques and approaches

• Strong cross-cultural, interpersonal and communication skills.

• Ability to establish strong relationships and engage with business groups to gain cooperation, foster collaboration, and influence outcomes in a positive way.

• Ability to effectively train others and adapt to individual learning styles.

• Ability to develop and recommend to management a course of action when systems or processes are found to be deficient.

• Ability to develop and implement procedures, training and oversight to ensure the integrity of data generated to support testing processes.

• Ability to work independently using knowledge and work experience.  Gathers input from colleagues and management to address issues. Actively surveils industry trends.

• Author and execute validation protocols and reports

• Advanced computer skills

• Interact as needed with outside vendors and consultants.

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 20 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.

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.