Senior Quality Assurance Specialist

Company: Disability Solutions
Location: Athens
Posted on: September 28, 2024

Job Description:

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.jnj.com/.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.\rKey Responsibilities:

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• 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.\r\r

Keywords: Disability Solutions, Athens , Senior Quality Assurance Specialist, Other , Athens, Georgia