Lead Quality Specialist - Business Process Management

GE HealthCare • Arlington Heights, IL

1d • $117,040 - $175,560 • Onsite

About The Position

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 HealthCare 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.

Requirements

• 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

Nice To Haves

• 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 HealthCare experience

Responsibilities

• 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.

Benefits

• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
• Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees