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Quality Specialist
Sanford, NC
$40-45/HR
3rd Shift
Quality Specialist will evaluate and review manufacturing related activities in support of clinical and commercial batch production.
Quality Specialist Responsibilities:
Quality Specialist Requirements:
Sanford, NC
$40-45/HR
3rd Shift
Quality Specialist will evaluate and review manufacturing related activities in support of clinical and commercial batch production.
Quality Specialist Responsibilities:
- Approve change control activities to ensure compliance to procedures/GMPs.
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Contribute to Quality Assurance activities by performing manufacturing floor support, batch record review and other duties as assigned.
- Independently assess production activities to determine potential Quality and Operational impact.
- Suggest improvements and conduct continuous improvement activities.
- Document deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
- Provide Quality Review and oversight of site cGXP documentation related to the Production Operations and site activities to ensure compliance with global regulatory agencies and quality standards.
- Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Quality Specialist Requirements:
- Eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
- Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
- Proactive approach and strong critical thinking skills.
- Effectively manages stressful situations, able to focus on task regardless of circumstances and stress induced pressure.
- Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, Quality Tracking System (Trackwise), Veeva Vault, LIMS.
- Previous experience in Quality Assurance strongly preferred.
- Previous experience in QC, Manufacturing and/or Engineering strongly preferred.
