Sr. QA Specialist

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

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 Description Roles and Responsibilities

• Handle deviation/OOS/CAPA to ensure deviations are reviewed, assessed, evaluated to comply with the cGMP. Collaborate and work together with other departments to allow closure of preventive and corrective actions and ensuring the overall smooth running of the deviation system.
• Handle product complaints to ensure that customer complaints are investigated, and documented appropriately according to procedures, well communicate response with sales or hospitals.
• Responsible for coordinating with suppliers to conduct investigations and advance related work, ensuring that the entire process (including root cause identification and the development of corrective and preventive actions and closure timely) being complied with requirements of the deviation system.
• Lead cross-department project to ensure project smoothly running against schedule.
• Liaise with Operations personnel to ensure regulatory and quality requirements are met during routine operations.
• Monitor the manufacturing process/documentation/computerized system to meet with procedure, GMP and data integrity requirements.
• Monitor and aid the implementation of continuous improvements and process changes.
• Take part in internal and external audit, be responsible for audit response and implementing improvement.
• Coordinate QA activities including deviation/OOS/complaint management, revision of SOPs, QA routine tasks and new projects.
• Review of batch manufacturing records and the process of manufacture, make the decision to release/reject the product in compliance with all licenses and GMP requirements.

Required Qualifications

• B.S. Degree in technical field, better major in pharmacy, food science, chemistry etc.
• Minimum 5-year experience in pharmaceutical industry or a medical device. Personnel with work experience in QA or QC will be preferred.
• Thorough knowledge of national and international GMP requirements.
• Fluent English in speaking, listening, reading and writing.
• Proficiency in Microsoft Office Suite.

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

Inclusive & Diversity Paragraph GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

Behavior Statement 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.

Total Reward Statement 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.

Additional Information Relocation Assistance Provided: No