QA Associate III at The Fountain Group

Hello,
My name is Arnold, and I am a Senior Talent Acquisition Consultant with The Fountain Group.  We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team. I believe you have a great background and would love to discuss what's most important to you then compared to see if it matches our job.  
Currently I have an opening for QA Associate located in Athens, GA. Details for the position are as follows:
Pay rate: $28.19/hr.
Job Description/Responsibilities:

• 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.

 
Qualifications:

• Bachelors degree in Life Sciences or Engineering
• 5-7 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.
• SAP
• 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.

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
If you are interested in hearing more about this position or other opportunities I may have please respond to this posting with your updated resume or contact me at (813) 425-2220, please reply/email your resume directly to Arnold.Suwan@TheFountainGroup.com
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.