GE HealthCare Lead Quality Analyst 

United States, Illinois 

34824794

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 / 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's degree (or high school diploma/GED plus 4 years experience in a QA/RA or medicaldevice/pharmaceuticalenvironment)

1+ year of experience in a medical device or pharmaceutical industry.

Thorough familiarity with cGMPs of sterile product manufacture

Must be willing to perform weekend work on a rotating schedule

1+ year of 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