Quality Assurance Specialist
About The Position
Quality Assurance & GMP Compliance Support compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements. Collaborate with department management to investigate quality issues and develop strategies to prevent recurring deviations. Report potential quality or compliance concerns to Quality Management in a timely manner. Create, update, and review Standard Operating Procedures (SOPs) and other controlled documents in compliance with GMP requirements. Investigations & Complaint Management Lead, initiate, track, and trend investigations related to customer product complaints. Review reported complaints for accuracy and completeness prior to triaging. Assist subject matter experts with root cause analysis and corrective action activities. Utilize technical writing practices to ensure investigations are clear, concise, and well-documented. Provide customer support related to product complaints through phone and email communication. Quality Systems & Data Management Compile, maintain, and analyze quality performance metrics and trend data. Support MasterControl system administration activities, including troubleshooting and process improvements. Maintain accurate and compliant quality records and documentation. Audits & Regulatory Support Perform internal audits to assess compliance with regulatory, quality, and procedural requirements. Participate in external audits conducted by regulatory agencies and provide documentation and audit support as needed. Support continuous improvement initiatives resulting from audit findings and quality trends. Calibration & Equipment Oversight Ensure equipment calibrations are completed according to defined schedules and GMP requirements. Review and approve calibration certificates and maintenance records to verify equipment remains within acceptable operating parameters. Coordinate follow-up activities related to equipment calibration or maintenance issues.
Requirements
- Compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements.
- Investigation of quality issues and development of strategies to prevent recurring deviations.
- Reporting of potential quality or compliance concerns to Quality Management.
- Creation, updating, and review of Standard Operating Procedures (SOPs) and other controlled documents.
- Leading, initiating, tracking, and trending investigations related to customer product complaints.
- Reviewing reported complaints for accuracy and completeness.
- Assisting subject matter experts with root cause analysis and corrective action activities.
- Utilizing technical writing practices for clear, concise, and well-documented investigations.
- Providing customer support related to product complaints.
- Compiling, maintaining, and analyzing quality performance metrics and trend data.
- Supporting MasterControl system administration activities.
- Maintaining accurate and compliant quality records and documentation.
- Performing internal audits to assess compliance.
- Participating in external audits and providing documentation and support.
- Supporting continuous improvement initiatives.
- Ensuring equipment calibrations are completed according to schedules and GMP requirements.
- Reviewing and approving calibration certificates and maintenance records.
- Coordinating follow-up activities related to equipment calibration or maintenance issues.
Responsibilities
- Support compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements.
- Collaborate with department management to investigate quality issues and develop strategies to prevent recurring deviations.
- Report potential quality or compliance concerns to Quality Management in a timely manner.
- Create, update, and review Standard Operating Procedures (SOPs) and other controlled documents in compliance with GMP requirements.
- Lead, initiate, track, and trend investigations related to customer product complaints.
- Review reported complaints for accuracy and completeness prior to triaging.
- Assist subject matter experts with root cause analysis and corrective action activities.
- Utilize technical writing practices to ensure investigations are clear, concise, and well-documented.
- Provide customer support related to product complaints through phone and email communication.
- Compile, maintain, and analyze quality performance metrics and trend data.
- Support MasterControl system administration activities, including troubleshooting and process improvements.
- Maintain accurate and compliant quality records and documentation.
- Perform internal audits to assess compliance with regulatory, quality, and procedural requirements.
- Participate in external audits conducted by regulatory agencies and provide documentation and audit support as needed.
- Support continuous improvement initiatives resulting from audit findings and quality trends.
- Ensure equipment calibrations are completed according to defined schedules and GMP requirements.
- Review and approve calibration certificates and maintenance records to verify equipment remains within acceptable operating parameters.
- Coordinate follow-up activities related to equipment calibration or maintenance issues.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
