Job Title:
Quality Assurance Specialist
About the Role:
This position plays a vital role in ensuring that our operations meet the highest standards of quality and compliance.
Key Responsibilities:
* Conduct thorough audits and reviews of batch documentation to guarantee adherence to regulatory requirements.
* Review and approve production and analytical documentation to ensure conformance to applicable SOPs, GMPs, and regulatory needs.
* Develop strong working relationships with cross-functional teams to foster collaboration and resolve issues efficiently.
* Manage product recalls and stock recoveries as necessary, identifying areas for continuous improvement.
* Create and maintain assigned Standard Operating Procedures (SOPs).
* Analyze complaints and deviation investigations, change controls, and Corrective Action Preventative Actions (CAPA).
* Assist in the onboarding process for new employees and provide training to other staff members.
Requirements:
* Demonstrated expertise in quality assurance principles and practices.
* Familiarity with relevant regulations and industry standards.
* Excellent communication and interpersonal skills.
* Ability to analyze complex data and draw meaningful conclusions.
* Proficiency in creating and maintaining accurate records and reports.