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QA Associate III

Athens, GA 30601

Posted: 04/24/2024 Employment Type: Contract Job Category: QA/Automation Job Number: 604802 Is job remote?: No Country: United States

Job Description


Duties:    
  • Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation.
  • Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
  • Information must be proactively shared across QA and the business including the on-going training of junior team members.  
  • Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations.
  • Works closely with others to determine root cause and potential preventative/corrective actions.
  • Ensures support for the timely  closure of investigations.
  • Provides guidance directives regarding remediation activities required to continue production.  
  • Oversees execution of remediation/CAPA activities required to continue production or move a process along.  
  • Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.  
  • Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
  • This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.  
  • Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities.  
  • Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.  
  • Ensures all specifications are met and that requirements are completed and acceptable.
  • Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs  and SOPs and current manufacturing regulations and site procedures.
  • Analyzes and reports findings to appropriate departments.  
  • Works closely with others to recognize opportunities for improvement and drive change through the use of BIFI’ Quality Systems.   


Skills:    
  • Capability to establish good relationships with others who have different values, cultural styles and perspectives.
  • Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.  
  • Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.  
  • Strong independent judgment and decision making abilities required.
  • Project management experience
  • Strong knowledge of relevant regulatory guidances.
  • Demonstrated problem-detection and problem-resolution skills required.
  • Strong conflict resolution and negotiation skills required.
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; good interpersonal skills. 


Education:    
  • Bachelors degree in Life Sciences or Engineering


Pay Rate Range: $20-28/hr. Salary will be commensurate with experience 
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About Athens, GA

Discover exciting job opportunities in the vibrant region surrounding Athens, Georgia! Nestled in the heart of the Peach State, Athens offers a blend of Southern charm and progressive energy that makes it a standout choice for your next career move. Home to the iconic University of Georgia, Athens is known for its lively music scene, historic architecture, and delectable southern cuisine. With a plethora of art galleries, theaters like the Classic Center, and sports venues like Sanford Stadium, this area provides endless opportunities for personal and professional growth. Explore our job listings today and unlock your potential in this enchanting city filled with rich history and endless charm.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.