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.
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
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
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.
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