QA Auditor I
AVEVA DRUG DELIVERY SYSTEMS INC
Summary
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.
Job description
Job 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
Qualifications
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.
Requirements
- High School Diploma or equivalent
- Two-years of college preferred
- Two-four years related experience and/or training in a manufacturing or quality environment
- Ensure GMP compliance throughout the facility
- Enforce cGMP regulations and 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 manufacturing and packaging
- On-line reviewing batch documentation for compliance
- Preparation and execution of AQL plans
- Completion of QA Envelope Documentation
- Perform Evaluation / impound of Substandard Materials
- Sampling products for on-line inspection, AQLs, stability, Reworks, Controlled Substance
- Monitor In-Process product defects Tracking, Trending Assessment
- Monitor Preparation of Product Defect Samples for Defect Library
- Conduct surface swab sampling and swab release
- Support Annual Product Inspection (APR)
- Execution of QAIP walkthroughs
- Collaborate with Production Supervisor/Section Leader to resolve product quality issues
- Identifies quality concerns and escalates to management
- Initiation of Investigation as required
- Works as a member of a team
Company overview
AVEVA Drug Delivery Systems Inc is a global leader in transdermal drug delivery technology, headquartered in Miramar, Florida. Founded in 2003, the company specializes in developing and manufacturing controlled-release transdermal products that address unmet market needs while providing high-quality, affordable alternatives to brand-name pharmaceuticals. AVEVA offers comprehensive research, development, and manufacturing capabilities for transdermal pharmaceutical products, leveraging sophisticated technologies to enhance bioavailability, minimize pharmacokinetic peaks and troughs, improve tolerability, and increase patient compliance. The company has achieved commercial success with approved products including Fentanyl Transdermal Patch for pain management, Clonidine Transdermal Patch for hypertension, and Clearback Nicotine Transdermal Patch for smoking cessation. AVEVA serves pharmaceutical partners worldwide with customized transdermal drug delivery systems designed for specific chemical entities, employing innovative techniques such as computer modeling and cadaver skin permeation testing to overcome formulation challenges and create individualized solutions.