Quality Assurance Specialist

2 weeks ago

Athens, Georgia, United States Spectraforce Technologies Inc Full time
Job Title: QA Associate III

At Spectraforce Technologies Inc, we are seeking a highly skilled QA Associate III to join our team. As a QA Associate III, you will play a critical role in ensuring the quality and compliance of our manufacturing operations.

Key Responsibilities:
  • Execute QA operations and oversee junior team members in assessing, evaluating, and reviewing operations against cGMPs to ensure real-time observation of activities, issue identification/resolution, and proper documentation.
  • Provide guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assist in resolving issues identified.
  • Identify, classify, and report deviations, as appropriate, and work closely with others to determine root cause and potential preventative/corrective actions.
  • Ensure support for the timely closure of investigations and provide guidance directives regarding remediation activities required to continue production.
  • Oversee the execution of remediation/CAPA activities required to continue production or move a process along and resolve critical issues within the assigned area.
  • Provide quality oversight to the change management system for complex Minor and/or Major classified Change Controls, including plan creation oversight, verification of changes against local SOPs and regulatory compliance, and communication/escalation of potential issues of broader impact to the business.
  • Perform independent technical review of documentation, including Batch Production Records, during and post-execution of cGMP activities and have authority to sign off/qualify/train junior staff on QA Operation responsibilities.
  • Ensure all specifications are met and that requirements are completed and acceptable, and ensure all issues/documentation associated with each process in the 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.
  • Analyze and report findings to appropriate departments and work closely with others to recognize opportunities for improvement and drive change through the use of client's Quality Systems.
Requirements:
  • 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, as well as project management experience and strong knowledge of relevant regulatory guidances.
  • Demonstrated problem-detection and problem-resolution skills required, along with strong conflict resolution and negotiation skills and excellent verbal and written communication skills.
  • Bachelor's degree in Life Sciences or Engineering.

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