SENIOR QUALITY ASSURANCE SPECIALIST

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Senior Quality Assurance 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.
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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.
In this role you will provide Quality Assurance batch record review and release associated with the manufacture of safe, effective Active Pharmaceutical Ingredients in accordance with company Standard Operating Procedures, policies and current Good Manufacturing Practices.
Key Responsibilities.
Review and assess batch records for completeness, accuracy, and adherence to GMP regulations, specifications and company Standard Operating Procedures (SOPs) Maintain accurate and complete documentation of all batch record review activities.
Give timely disposition to manufactured products in the ERP system based upon result of testing and compliance with all requirements.
Prepare Certificate of Analysis, for finished Product.
Responsible for overseeing controls and standards for Nonconformance, CAPAs and Change Control.
Contribute to continuous improvement efforts by finding opportunities to enhance batch record accuracy and efficiency.
Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.
Drafts, reviews, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.
Partners with internal production planning to ensure awareness and alignment with production planning and delivery schedules.
This position is not a supervisory role.
However, this role is expected to collaborate and direct Quality Assurance requirements to impact overall site quality performance.
Qualifications Education.
A Bachelor’s degree or University equivalent in Engineering or related scientific, planning or business field required.
Experience and Skills.
Required.
A minimum of three (3) years of related work experience in a GMP pharmaceutical or medical device manufacturing environment.
Organized, diligent, and able to multi-task and prioritize responsibilities.
Collaboration and influence leadership skills to partner effectively across functions and operating units.
Excellent communication skills, able to inspire trust and build credibility.
Must have skills to perform tasks without continuous supervision but seeking input as needed.
Strong problem solving (RCA/RCPS) skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.
Preferred.
Knowledge of ICH Guidelines and US FDA 21 CFR 210 and 211 Experience with SAP or other ERP system Working knowledge of Microsoft Office software programs.
Ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations.
Understand Quality Systems regulation requirements for pharmaceuticals and medical devices.
Able to lead multiple initiatives daily while being flexible and adaptable to shifting priorities when needed.
Ability to apply risk management philosophy to business processes, decisions and data.
Other.
This position is in Athens, GA and may require up to 10% domestic or international travel.
This position requires 100% of the work on-site in support of Manufacturing.
Must be willing to work beyond traditional hours to support needs of business partners on a scheduled or emergency basis.
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.
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