Aveva Drug Delivery Systems
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QA Auditor I
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Aveva Drug Delivery Systems 3 days ago Be among the first 25 applicants Join to apply for the
QA Auditor I
role at
Aveva Drug Delivery Systems About Us:
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 Details
Miramar, FL $25.00 - $25.00 Hourly Day
Description
About Us:
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.
Preference given to candidates residing locally to Aveva Miramar due to immediate onsite needs.
Job 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 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.
Key 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
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.
Experience
Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facilities.
Knowledge, Skills And Abilities
Excellent written and verbal English communication skills. Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience in JD Edwards ERP system is an asset Superior interpersonal skills and ability to work effectively in a team environment within and outside the department Ability to manage multiple priorities in a fast-paced environment Attention to detail
Benefits
Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
Medical/Dental/Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday
Equal Opportunity Employer Seniority level
Seniority level Entry level Employment type
Employment type Part-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Aveva Drug Delivery Systems by 2x Get notified about new Quality Assurance Auditor jobs in
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QA Auditor I
role at
Aveva Drug Delivery Systems 3 days ago Be among the first 25 applicants Join to apply for the
QA Auditor I
role at
Aveva Drug Delivery Systems About Us:
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 Details
Miramar, FL $25.00 - $25.00 Hourly Day
Description
About Us:
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.
Preference given to candidates residing locally to Aveva Miramar due to immediate onsite needs.
Job 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 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.
Key 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
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.
Experience
Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facilities.
Knowledge, Skills And Abilities
Excellent written and verbal English communication skills. Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience in JD Edwards ERP system is an asset Superior interpersonal skills and ability to work effectively in a team environment within and outside the department Ability to manage multiple priorities in a fast-paced environment Attention to detail
Benefits
Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
Medical/Dental/Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday
Equal Opportunity Employer Seniority level
Seniority level Entry level Employment type
Employment type Part-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Aveva Drug Delivery Systems by 2x Get notified about new Quality Assurance Auditor jobs in
Hollywood, FL . Quality Assurance, Quality Systems Manager
Manager, Quality Assurance & Nutrition, BK, US&C
Assurance Manager, Quality Management - IS Assurance
Miami, FL $100,000.00-$150,000.00 18 hours ago Manager - Quality Assurance & Food Safety
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Fort Lauderdale, FL $100,000.00-$150,000.00 18 hours ago Assurance Experienced Senior, Quality Management
Fort Lauderdale, FL $80,000.00-$125,000.00 18 hours ago Assurance Experienced Senior, Quality Management
Miami, FL $80,000.00-$125,000.00 18 hours ago Doral, FL $105,100.00-$231,100.00 1 month ago Lauderhill, FL $50,000.00-$55,000.00 1 month ago Quality Assurance / Improvement Specialist
Doral, FL $112,450.00-$203,275.00 2 weeks ago Quality Assurance (Complaint & CA/PA) Specialist
Doral, FL $105,100.00-$231,100.00 1 month ago Quality Assurance Manager (Ground Handling)
Coral Springs, FL $24.00-$25.00 21 hours ago Quality Assurance Associate, Produce Redistribution Centers
Quality Assurance Associate, Produce Redistribution Centers
Respiratory Therapy Quality Assurance Specialist
Manager, Quality Assurance Engineer AI/ML
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr