Sr. QA Specialist

[Janssen Vaccines] Sr. QA Specialist W

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 pharmaceutical, medical devices and diagnostics markets, 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 .
DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.
1.

포지션:
Sr. QA Specialist (7-9 years of experience)

2.

계열사:
얀센백신 (Janssen Vaccines)

3.

근무지:
인천 송도

4.

근무 형태:
Regular

[Main responsibility]

• Provides quality support of manufacturing activities (e.g., Aseptic Drug Product processing, Validation of cleaning & sterilization) / utility management activities (e.g., HVAC, water system, BMS, maintenance, calibration)
• Performs QA on the shop floor activities and support of continuous quality improvement initiatives to cultivate a culture of proactive quality in collaboration with cross-functional team
• Reviews related procedures and documents
• Support non-conformance investigations and CAPAs in compliance with GMP requirements and company procedures
• Evaluates change proposals for impact and risk through change management/change control system and support coordination of cross-functional implementation plans
• Supports audit / inspectional readiness activities to prepare the site for internal independent audits and health authority inspection
• Perform tasks in a manner consistent with the safety policies, quality systems, and FDA/EU requirement
• Provide leadership and insight to assist the team performance as a senior staff in the team.
• Conducts / supports training on decisions / conclusions of manufacturing / engineering activities from quality point of view

[Requirement]

• A minimum of Bachelor's degree is required, in life sciences or related field, such as Biology, Chemistry, Microbiology, Engineering, Pharmacy, etc.
• 
  More than 7 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
• Represent Quality in technical and/or other tactical cross-functional meetings
• Ability to identify opportunities for improvement
• Word processing, presentation, spreadsheet and database skills

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Qualifications
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Primary Location Asia Pacific-South Korea-Incheon-Yeonsu-gu

Organization Janssen Vaccines(8856)

Job Function Quality Assurance

Req ID: W

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