Aveva Drug Delivery Systems
Quality Assurance in Process (QAIP) Auditor I
Aveva Drug Delivery Systems, Fort Lauderdale, Florida, us, 33336
Overview
Quality Assurance in Process (QAIP) Auditor I is a role at Aveva Drug Delivery Systems. The QAIP Auditor I supports Manufacturing, Packaging, R&D, Technical Operations, Engineering and QC operations by performing line clearance, visual inspection of finished products, sampling from production, and conducting in-process and packaging audits to ensure conformance to quality standards. Daily walkthroughs help ensure the facility is audit-ready at all times. Job Details
Location: Tamarac, FL Salary: $25.00 hourly Employment type and schedule: Part-time Job Summary
The Quality Assurance In-Process (QAIP) Auditor I is responsible for day-to-day support to various operations by performing room and equipment line clearance, visual inspection of finished products, collecting stability and retain samples, conducting in-process and packaging audits to ensure intermediate materials and packaged products conform to established quality standards, and performing on-line batch record reviews in real time. The QAIP auditor conducts daily walkthroughs to maintain an audit-ready facility. Responsibilities
Ensure GMP compliance throughout the facility Enforce cGMP regulations and Aveva’s 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 audits of all manufacturing and packaging areas; online review of batch documentation for compliance to batch records and product specifications Prepare and execute AQL plans Complete QA Envelope Documentation (Room Release, Start up, and executed AQL plans) Perform evaluation/impoundment of Substandard Materials Sample products for online inspection, AQLs, stability, reworks, controlled substances, etc. Monitor in-process product defects tracking and trend assessment Prepare product defect samples for the Defect Library Conduct surface swab sampling and swab release based on test results Support Annual Product Inspection (APR) and coordinate the QA Reserve Sampling Room Execute QAIP walkthroughs Ensure 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 Identify quality concerns and escalate to management as appropriate Initiate investigations as required Work as a team to achieve outcomes Operate in accordance with the Code of Conduct, Business Ethics, and all regulatory, compliance and safety requirements Support company values: Innovate, Evolve, and Excel Other duties assigned by QA Management Qualifications
Education: High School Diploma or equivalent Two years of college preferred Two to four years of related experience in pharmaceutical manufacturing or similar industry Equivalent combination of education and experience considered Knowledge, Skills, and Abilities: Excellent written and verbal communication in English Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint) Experience with JD Edwards ERP is a plus Strong interpersonal skills and ability to work effectively within and outside the department Ability to manage multiple priorities in a fast-paced environment Keen attention to detail Benefits
Medical, Dental, and Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday Equal Opportunity Employer Job Details (continued)
Seniority level: Entry level Employment type: Part-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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Quality Assurance in Process (QAIP) Auditor I is a role at Aveva Drug Delivery Systems. The QAIP Auditor I supports Manufacturing, Packaging, R&D, Technical Operations, Engineering and QC operations by performing line clearance, visual inspection of finished products, sampling from production, and conducting in-process and packaging audits to ensure conformance to quality standards. Daily walkthroughs help ensure the facility is audit-ready at all times. Job Details
Location: Tamarac, FL Salary: $25.00 hourly Employment type and schedule: Part-time Job Summary
The Quality Assurance In-Process (QAIP) Auditor I is responsible for day-to-day support to various operations by performing room and equipment line clearance, visual inspection of finished products, collecting stability and retain samples, conducting in-process and packaging audits to ensure intermediate materials and packaged products conform to established quality standards, and performing on-line batch record reviews in real time. The QAIP auditor conducts daily walkthroughs to maintain an audit-ready facility. Responsibilities
Ensure GMP compliance throughout the facility Enforce cGMP regulations and Aveva’s 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 audits of all manufacturing and packaging areas; online review of batch documentation for compliance to batch records and product specifications Prepare and execute AQL plans Complete QA Envelope Documentation (Room Release, Start up, and executed AQL plans) Perform evaluation/impoundment of Substandard Materials Sample products for online inspection, AQLs, stability, reworks, controlled substances, etc. Monitor in-process product defects tracking and trend assessment Prepare product defect samples for the Defect Library Conduct surface swab sampling and swab release based on test results Support Annual Product Inspection (APR) and coordinate the QA Reserve Sampling Room Execute QAIP walkthroughs Ensure 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 Identify quality concerns and escalate to management as appropriate Initiate investigations as required Work as a team to achieve outcomes Operate in accordance with the Code of Conduct, Business Ethics, and all regulatory, compliance and safety requirements Support company values: Innovate, Evolve, and Excel Other duties assigned by QA Management Qualifications
Education: High School Diploma or equivalent Two years of college preferred Two to four years of related experience in pharmaceutical manufacturing or similar industry Equivalent combination of education and experience considered Knowledge, Skills, and Abilities: Excellent written and verbal communication in English Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint) Experience with JD Edwards ERP is a plus Strong interpersonal skills and ability to work effectively within and outside the department Ability to manage multiple priorities in a fast-paced environment Keen attention to detail Benefits
Medical, Dental, and Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday Equal Opportunity Employer Job Details (continued)
Seniority level: Entry level Employment type: Part-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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