QUALITY SYSTEMS SPECIALIST II

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Systems Specialist to be located in Athens, GA! 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 https://www.
nj.
om/.
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.
The Quality Systems Specialist will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.
Key Responsibilities.
Ensure compliance to governing Quality Systems policies and procedures.
Perform gap assessments against global documents.
Drive alignment and efficiencies between global and local processes.
Provide advisement on good documentation practices (GDP).
Provide coordination support for Quality Boards including Quality Systems Management Review, Change Review and CAPA Review Board meetings.
Review wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, and Forms.
Support non-conformance investigations, including root cause analysis and CAPA planning activities.
Participate in internal and external Quality Audits and support inspection readiness initiatives.
Provide administrative customer service support for internal customers (i.
.
GMP functional areas) related to electronic Quality Management Systems (eQMS) (Document management and e-Learning systems).
Excellent organizational, time management and interpersonal and follow-up skills are required.
Qualifications Education.
Minimum of a Bachelor's degree or University equivalent degree with focus in a technical or scientific area.
Experience and Skills.
Required.
A minimum of two (2) years of related work experience in the life sciences, pharmaceutical and/or medical device industries.
Hands-on Quality experience & applied knowledge of cGMPs is required.
Demonstrates the ability to stay organized, pay attention to important details, and effectively balance multiple tasks and priorities.
Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.
Ability to work on complex issues with minimal direction and to think analytically.
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Preferred.
Familiarity with electronic Quality Management systems (Trackwise, Veeva, Summit or equivalent system).
Experience with creating tailored learning content and presentations, a plus.
Other.
This position is in Athens, GA and may require up to 10% domestic or international travel.
Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.