Lead Quality Analyst

Job Description SummaryGE Healthcare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health. With us, you can touch the lives of thousands of people globally and make every moment matter in your career. This position involves working within the QA department to provide direct oversight for pharmaceutical manufacturing operations, conducting product release, quality audit, facilitate continuous improvement, investigate customer complaints. 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 operations

Participating in audits, together with follow up. This includes internal audits as well as external (eg. 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 / 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

Qualifications/Requirements:

Bachelor degree (or high school diploma/GED plus 4 years experience in a QA/RA or medical device/pharmaceutical environment)

1 year experience in a medical device or pharmaceutical industry.

1 year experience with CAPA systems, including complaint handling.

Thorough familiarity with cGMPs of sterile product manufacture

Must be willing to perform weekend work on a rotating schedule

Desired Characteristics:

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

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.We 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-onsite#LI-NV1Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf) . 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 HealthCare 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 HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.Relocation Assistance Provided: No