Senior QA Specialist, Compliance

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Quality

Quality Assurance

Professional

Wilson, North Carolina, United States of America

The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina. The QA Specialist reports to the Senior Manager, Quality Assurance.

• Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues.
• Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures. Facilitate timely resolution through coordination with relevant department and teams.
• Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures.
• Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents.
• Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments.
• Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
• Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance.

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

• Bachelor's degree in a scientific or engineering discipline is required.
• Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role.
• Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards.
• Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
• Experience with regulatory inspections and response to observations. (QA Specialist, Compliance)
• Proficiency in risk management methodologies such as FMEA.

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic…