QA Auditor I

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL

2d•$25 - $25•Onsite

About The Position

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.

Requirements

High School Diploma or equivalent.
Two to four years of related experience and/or training.
Relevant experience working in a pharmaceutical manufacturing or similar industry.
Equivalent combination of education and experience will be considered.
Excellent written and verbal communication skills in English.
Proficiency with Microsoft Office products (Word, Excel, Access, PowerPoint).
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.

Nice To Haves

Two years of college preferred.
Experience with JD Edwards ERP system is a plus.

Responsibilities

Perform day-to-day support to 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.
Perform daily walkthroughs ensuring that the facility is Audit ready at all times.
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.
Perform Room and equipment line clearance for the packaging process.
Conduct In-process audit of all areas of manufacturing and packaging; on-line reviewing batch documentation for compliance to batch record requirements and product specifications.
Prepare and execute AQL plans.
Complete the QA Envelope Documentation (Room Release, Start up, and executed AQL plans).
Perform Evaluation / impound of Substandard Materials.
Sample products for on-line inspection, AQLs, stability, Reworks, Controlled Substance, etc.
Monitor the In-Process product defects.
Track and Trend 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.
Initiate 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 established regulatory, compliance and safety requirements.
Perform all work in support of company Values: Innovate, Evolve, and Excel.
Perform other duties assigned as assigned by the QA Management.