Quality Specialist II - Athens, United States - Disability Solutions

Description

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Specialist II to be located at 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

This role ensures compliance with regulatory requirements and internal company procedures. Ensures company products follow internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Responsible for final product release decision in adherence to appropriate standard operating procedures and specifications.

Key Responsibilities :

• Assesses compliance with cGMP regulations on difficult and complex technical issues.
• Performs batch record review, control record review, and product disposition, including preparation of Certificates of Analysis.
• Participates and assists with regulatory audits and agency inspections.
• Participant in internal and customer audits; including completion of Facility and Systems Questionnaires.
• Schedules, leads, and / or participates in the quarterly Site Quality Management Review.
• Coordinates and completes associated activities with regards to customer complaints and inquiries
• Drafts, reviews, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications within the controlled document system.
• Reviews, approves, and, in some cases, investigates non-conformances that could affect the quality of pharmaceuticals and medical devices.
• Drives continuous proactive improvement of site quality system Performs gap assessments with quality systems and Standards to ensure compliance.
• Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.
• Supports strategic site and segment projects and initiatives, including New Product Introductions.
• 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.