QA Auditor I

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 52,000 - 68,000; Full time

Job summary

Aveva Drug Delivery Systems Inc seeks an QAIP Auditor I to support Manufacturing, Packaging, R&D, Technical Operations, Engineering, and QC. Responsibilities include room clearance, on-line batch record review, and sampling for stability and retain materials to ensure GMP compliance.

Requirements include high school diploma or equivalent with further college work, strong English communication, and familiarity with MS Office; JD Edwards ERP is a plus.

Qualifications

• Excellent written and verbal English communication skills.
• Experience with Microsoft Office products (Word, Excel, PowerPoint, Access).
• Experience with JD Edwards ERP is a plus.

Responsibilities

• Perform room and equipment line clearance and in-process audits.
• Review batch documentation online for compliance and product specs.
• Collect stability and retain samples from production lines.
• Conduct on-line batch record reviews and QA envelope documentation.

Skills

English communication

Attention to detail

Team collaboration

Education

High School Diploma or equivalent, with 2 years college

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Access

JD Edwards ERP

Job 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 byperforming 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 conforms 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 Responsibilities:Ensure GMP compliance throughout the facilityEnforce cGMP regulations and Aveva’s Standard Operating Procedures (SOPs)Maintain knowledge of Production Manufacturing and Packaging SOPsApprove Shipper labels/roll labels, and clinical labelsRoom and equipment line clearance for the packaging processIn-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 plansCompletion of the QA Envelope Documentation (Room Release, Start up, and executed AQL plans)Perform Evaluation / impound of Substandard MaterialsSampling products for on-line inspection, AQLs, stability, Reworks, Controlled Substance, etc.Monitor the In-Process product defects Tracking, Trending AssessmentMonitor the Preparation of the Product Defect Samples for the Defect LibraryConduct surface swab sampling and swab release based on swab test resultsSupport Annual Product Inspection (APR) and Coordination of the QA Reserve Sampling RoomExecution of QAIP walkthroughsComply 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 appropriateInitiation 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 ExcelOther duties assigned as assigned by the QA ManagementEducationHigh 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.knowledge, Skills and AbilitiesExcellent written and verbal English communication skills.Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience in JD Edwards ERP system is an assetSuperior interpersonal skills and ability to work effectively in a team environment within and outside the departmentAbility to manage multiple priorities in a fast-paced environmentAttention to detailExperienceExperience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility