DifGen Pharmaceuticals
Quality Assurance in Process (QAIP) Auditor I
DifGen Pharmaceuticals, Florida, New York, United States
Quality Assurance in Process (QAIP) Auditor I
Be among the first 25 applicants Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. Job Summary
The Quality Assurance In-Process (QAIP) Auditor I is responsible for 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 and Manufacturing In-process audits to ensure that intermediate materials and packaged products conform to established quality standards, and conducting on-line batch record review in real time. The QAIP auditors are also responsible for daily walkthroughs ensuring that the facility is audit-ready at all times. 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; online 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 online inspection, AQLs, stability, reworks, controlled substances, etc. Monitor In-Process product defects tracking and 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 Execute 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 Identify quality concerns and escalate to management as appropriate Initiation of investigation as required Work as a member of a team to achieve all outcomes Operate in accordance with our Code of Conduct and Business Ethics, and all regulatory, compliance and safety requirements Perform all work in support of company values: Innovate, Evolve, and Excel Other duties assigned by QA Management Education
High School Diploma or equivalent Two years of college preferred Two to four years of related experience and/or training in pharmaceutical manufacturing or a similar industry Equivalent combination of education and experience will be considered Knowledge, Skills, And Abilities
Excellent written and verbal communication skills in English Proficiency with Microsoft Office products (Word, Excel, Access, PowerPoint) Experience with JD Edwards ERP system 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 Seniority level
Entry level Employment type
Other Job function
Quality Assurance Industries: Pharmaceutical Manufacturing
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Be among the first 25 applicants Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide. Job Summary
The Quality Assurance In-Process (QAIP) Auditor I is responsible for 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 and Manufacturing In-process audits to ensure that intermediate materials and packaged products conform to established quality standards, and conducting on-line batch record review in real time. The QAIP auditors are also responsible for daily walkthroughs ensuring that the facility is audit-ready at all times. 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; online 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 online inspection, AQLs, stability, reworks, controlled substances, etc. Monitor In-Process product defects tracking and 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 Execute 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 Identify quality concerns and escalate to management as appropriate Initiation of investigation as required Work as a member of a team to achieve all outcomes Operate in accordance with our Code of Conduct and Business Ethics, and all regulatory, compliance and safety requirements Perform all work in support of company values: Innovate, Evolve, and Excel Other duties assigned by QA Management Education
High School Diploma or equivalent Two years of college preferred Two to four years of related experience and/or training in pharmaceutical manufacturing or a similar industry Equivalent combination of education and experience will be considered Knowledge, Skills, And Abilities
Excellent written and verbal communication skills in English Proficiency with Microsoft Office products (Word, Excel, Access, PowerPoint) Experience with JD Edwards ERP system 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 Seniority level
Entry level Employment type
Other Job function
Quality Assurance Industries: Pharmaceutical Manufacturing
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