QA Specialist

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Incheon, Korea, Republic of Job Description: Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. Johnson & Johnson has announced preliminary plans to close the manufacturing facility in Incheon as part of a global supply chain reorganization. The plan remains under review and may evolve as discussions progress. Any potential closure would follow applicable legal requirements, regulatory approvals, and other customary conditions. If you accept this role, you would be employed by Janssen Vaccines on a fixed-term basis throughout the transition period, and your employment would be governed by Janssen Vaccines’ processes, programs, policies, and benefit plans. Additional details will be shared by Janssen Vaccines at the appropriate stage. 1. 포지션: QA Specialist 2. 계열사: 얀센백신 (Janssen Vaccines) 3. 근무지: 인천 송도 4. 근무 형태: Fixed term [Responsibilities] - Provides Quality support of laboratory activities in accordance with J&J requirement - Performs QA oversight to cultivate a culture of proactive quality in collaboration with cross-functional team - Reviews procedures (SOP/WI/TMD) and related documents - Reviews and approves non-conformance investigations (including OOS investigation) and CAPAs in compliance with GMP requirements and company procedures - Reviews equipment qualification documents including decommissioning documents - Evaluates change proposals for impact and risk through change management/change control system and support coordination of cross-functional implementation plans - Supports Data Integrity initiatives - Supports audit / inspectional readiness activities to prepare the site for internal independent audits and health authority inspection - Conducts / supports training on decisions / conclusions of laboratory activities from quality point of view - Perform tasks in a manner consistent with the safety policies and quality systems [Requirements] - A minimum of Bachelor’s degree is required, in life sciences or related field, such as Biology, Chemistry, Microbiology, Engineering, Pharmacy, etc. - 3-5 years of experience in a pharmaceutical industry, preferably in sterile manufacturing environment - Good verbal and written communication skills in English/Korean, facilitation, and presentation skills - Good technical writing skills - Strong organizational skills, including ability to follow tasks through to completion. Skills in prioritizing and meeting deadlines - Ability to identify opportunities for improvement - Word processing, presentation, spreadsheet and database skills Required Skills: Preferred Skills: