QA Auditor I at DifGen Pharmaceuticals in Miramar, FL 33025

Job description

• Overview
• Description
• The Quality Assurance In-Process (QAIP) Auditor I is responsible for the day-to-day support to the Manufacturing, Packaging, R & D, Technical Operations, Engineering and QC operations by
• performing room and equipment line clearance, visual inspection of finished products, collecting stability and retain samples from the production line, conducting Packaging, Manufacturing In-process audits to ensure that the Intermediate materials and packaged products conform to the established quality standards and conducting on-line batch record review in real time. In addition, the QAIP auditors are responsible for daily walkthroughs ensuring that the facility is Audit ready at all times.

Responsibilities

• Ensure GMP compliance throughout the facility
• Enforce cGMP regulations and Aveva’s Standard Operating Procedures (SOPs)
• Maintain knowledge of Production Manufacturing and Packaging SOPs
• Approve Shipper labels/roll labels, and clinical labels
• Room and equipment line clearance for the packaging process
• In-process audit of all areas of manufacturing and packaging; on-line reviewing batch documentation for compliance to batch record requirements and product specifications.
• Preparation and execution of AQL plans
• Completion of the QA Envelope Documentation (Room Release, Start up, and executed AQL plans)
• Perform Evaluation / impound of Substandard Materials
• Sampling products for on-line inspection, AQLs, stability, Reworks, Controlled Substance, etc.
• Monitor the In-Process product defects Tracking, Trending Assessment
• Monitor the Preparation of the Product Defect Samples for the Defect Library
• Conduct surface swab sampling and swab release based on swab test results
• Support Annual Product Inspection (APR) and Coordination of the QA Reserve Sampling Room
• Execution of QAIP walkthroughs
• Comply with and ensure that all activities are performed according to Aveva’s facility and Department core SOPs and approved batch records.
• Collaborate with Production Supervisor/Section Leader to resolve product quality issues.
• Identifies quality concerns and escalates to management as appropriate
• Initiation of Investigation as required.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of company Values: Innovate, Evolve, and Excel
• Other duties assigned as assigned by the QA Management

Requirements

• Education
• High School Diploma or equivalent, and or two-years of college; and two-four years related experience and/or training; or equivalent combination of education and experience.

Skills

Required

• Knowledge of GMP and cGMP regulations
• Quality assurance and auditing skills
• Attention to detail
• Ability to perform visual inspections
• Ability to collect and handle samples
• Ability to review batch documentation
• Ability to escalate quality concerns
• Ability to work as part of a team

Benefits

• $25.00 - $25.00