Lead Quality Specialist - Business Process Management

Overview

Job Description Summary
:
This position involves working within the QA department to provide direct oversight for pharmaceutical manufacturing operations, conduct product releases, quality audits, facilitate continuous improvement, and investigate customer complaints while working in a fast-paced cross functional team environment.

GE Health Care is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

• Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations.
• Participating in audits, together with follow up. This includes internal audits as well as external (supplier) audits.
• Conducting QA activities including revision of SOPs, SAP QA work, and the issuance of protocols.
• Responsible for review of batch records and the release of all products, including raw material batches.
• Responsible for the review of non-conformances related to product manufacture and/or testing.
• Responsible for performing investigations arising from product complaints.
• Gathering and reporting metrics as required by the business.
• Provide Quality Assurance support for implementation of new products at the site.
• Support global QA initiatives as determined by the business.
• Responsible for PET QA distribution activities, ensuring compliance with applicable regulatory and quality requirements.
• Deliver PET QA distribution activities to established timelines, ensuring efficient execution and issue resolution.
• Develop, track, and present metrics related to PET QA distribution performance to support business objectives and continuous improvement.
• Collaborate cross-functionally across multiple functions and sites to align quality objectives and influence outcomes.
• Exercise independent judgment in day-to-day quality decisions, while recognizing and appropriately escalating issues that may impact product quality, compliance, or patient safety.

• Bachelor's degree (or high school diploma/GED plus 9 years experience in a QA/RA or medical device/pharmaceutical environment)
• 5+ years of experience in a pharmaceutical OR medical device industry
• Thorough familiarity with cGMPs of sterile product manufacture
• Must be willing to perform weekend work on a rotating schedule

• Experience with CAPA systems, including complaint handling
• Analytical & problem-solving skills/root-cause analysis
• Excellent oral and written communication skills
• Statistics education and or training
• Experience developing and tracking quality metrics
• Familiar with Continuous Improvement methodologies, including Six Sigma
• Demonstrated effective interpersonal and effective teamwork skills
• Ability to effectively multi-task (i.e. effectively handle competing priorities)
• Prior GE Health Care experience

GE Health Care offers a great work environment, professional development, challenging careers, and competitive compensation. GE Health Care is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE Health Care will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE Health Care does not currently require U.S. employees to be vaccinated against COVID-19, some GE Health Care customers have vaccination mandates that may apply to certain GE Health Care employees.

Relocation Assistance Provided:
No