HiringCafe
Posted 1w ago

Quality Assurance Associate

@ Vero Biotech
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Atlanta, Georgia, United States
OnsiteFull Time
Responsibilities:Monitor quality system, Perform QA release, Support internal audits
Requirements Summary:2+ years QA experience in FDA/cGMP environment; science degree preferred; strong communication; proficient in MS Word/Excel/Outlook; knowledge of GMP/regulations.
Technical Tools Mentioned:MS Word, MS Excel, Outlook, MS Access
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Job Description

Position Summary



Responsible for ensuring that the quality of products being manufactured meet the prescribed quality levels.  Performs Quality Assurance activities, including review of manufacturing and final product release activities. Performs Quality oversight/observations for in-process verification/inspection activities within manufacturing areas, such as reworks.



 



Essential Duties and Responsibilities



 





  • Monitors/reviews the quality system including records and results from processes and procedures to ensure product Quality and compliance for any/all products (i.e. cassettes/consoles).




  • Ensures documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.




  • Reviews Quality Controls records and certificates to ensure accuracy and acceptability of analytical results




  • Maintains knowledge of current regulatory requirements pertaining to drug/device manufacturing. 




  • Performs label control functions




  • Participates in investigations of quality issues as required.




  • Supports Quality functions for batch record and label issuance, personnel and material flow, and batch release.




  • Performs QA release of final products in accordance with procedures




  • Reviews Standard Operating Procedures (SOPs) for manufacturing processes (may assist with revisions as needed).




  • Participates in continuous improvement objectives to assure compliance with regulations.




  • Develops and/or maintains metrics and trending reports for compliance related activities.




  • Supports internal audits and regulatory inspections.




  • Leads and mentors Quality personnel, including promoting quality culture and supporting quality objectives.




  • Performs QA receiving, issuance inventory




  • Performs Quality observations and in-process inspection/verification activities, such as reworks, on the production floor to provide Quality oversight (as assigned by Management)




  • Reviews applicable logbooks




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    Other related duties as assigned