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Quality Assurance Specialist
2 months ago
The Quality Assurance Specialist plays a crucial role in ensuring compliance with cGMP regulations. This position involves identifying deviations, conducting investigations, and implementing corrective actions to maintain a compliant manufacturing environment.
Responsibilities:- Deviations and Investigations: Conduct initial deviation investigative phases, respond to customer calls, and facilitate the use of existing management processes.
- Process Controls: Perform area assessments, ensure SOP compliance, and leverage on-the-floor presence to proactively identify opportunities for improvement.
- Documentation and Systems: Administer deviations/investigation/PAC systems in Trackwise and control materials for compliance purposes in SAP.
- Final Release Inspection: Execute the final release inspection of packaging lines.
- Acceptance Sample Analysis: Perform acceptance sample analysis for validation and investigation support.
- Document Review: Responsible for the review and approval of controlled documents.
The work environment is representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment. The noise level is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bending, lifting, moving, and/or carrying up to approximately 20 pounds.
- Navigating office, lab, and/or plant floor working environments.
- Minimum of Bachelor's degree.
- Understanding of GMPs.
- Expertise in software applications such as MS Office, Windows, Acrobat Reader, TrackWise, and LMS.
- Knowledge of project management principles, practices, techniques, and tools.
$65,000 - $85,000 per year.
This salary estimate is based on industry standards for quality assurance specialists with similar experience and qualifications in the pharmaceutical industry.
