Lead Quality Analyst

Job Description

Job Description SummaryThis 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. Job DescriptionEssential Responsibilities:Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operationsParticipating 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 / testingResponsible for performing investigations arising from product complaintsGathering and reporting metrics as required by the businessProvide Quality Assurance support for implementation of new products at the site. Support global QA initiatives as determined by the businessQualifications/Requirements:Bachelor’s degree (or high school diploma/GED plus 7 years experience in a QA/RA or medical device/pharmaceutical environment)3+ years of experience in a pharmaceutical OR medical device industryThorough familiarity with cGMPs of sterile product manufactureMust be willing to perform weekend work on a rotating scheduleDesired Characteristics:1+ year of experience with CAPA systems, including complaint handlingAnalytical & problem-solving skills/root-cause analysisExcellent oral and written communication skillsStatistics education and or trainingExperience developing and tracking quality metricsFamiliar with Continuous Improvement methodologies, including Six SigmaDemonstrated effective interpersonal and effective teamwork skillsAbility to effectively multi-task (i.

e. effectively handle competing priorities)Prior GE HealthCare experienceWe expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity. 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. #LI-onsiteWe will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.

S. based positions only, the pay range for this position is $93,280.

00-$139,920. 00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case.

The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). 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.

EWJD3