QUALITY SYSTEMS SPECIALIST

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.
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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 the Quality Systems procedures and policies.
Advising personnel on good documentation practices (GDP).
Drive alignment and efficiencies between global and local processes.
Coordinate and conduct Quality Systems Review meetings.
Review wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, Forms.
Support non-conformance investigations, including cause analysis and documenting findings.
Participate in Internal and External Quality Audits and support the internal and customer audit program as needed.
Work closely with management and various team members to propose and complete improvements activities.
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Excellent organizational, time management and interpersonal and follow-up skills is required.
Maintain knowledge of all procedures, changes to specifications and new regulations.
Qualifications Education.
Minimum of an Associate's degree or equivalent degree with focus in technical or scientific area.
Experience and Skills.
Required.
A minimum one (1) year of related work experience.
Shows ability to stay organized, pays attention to important details, and effectively handles 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 think analytically.
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Preferred.
Familiarity with Quality Management systems (Trackwise or equivalent system).
Quality experience & knowledge of GMPs desired.
Knowledge in ERP systems for quality data process is preferred.
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.