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General Electric Lead QA Analyst in Arlington Heights, Illinois

Job Description Summary

GE 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.

Job Description

Essential 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.

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Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.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 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).

Relocation Assistance Provided: No

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