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.
Preferred
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Experience using electronic Quality Management Systems (eQMS), MasterControl preferred.
- Experience generating, analyzing, and interpreting quality metrics and trend data.
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Proficient in investigative methodologies, root cause analysis tools, and problem-solving techniques.
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5 year(s): Experience conducting investigations, root cause analysis, and CAPA activities within an FDA-regulated environment.
Required
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Bachelors or better in Science or related field
Preferred
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Time Management
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Critical Thinking
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Written Communication
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Self Starter
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Oral Communication
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Auditing
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Learning Management Systems
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Technical Writing
Preferred
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Team Player: Works well as a member of a group
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Innovative: Consistently introduces new ideas and demonstrates original thinking
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Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well
Preferred
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Work-Life Balance: Inspired to perform well by having ample time to pursue work and interests outside of work
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Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization
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Goal Completion: Inspired to perform well by the completion of tasks
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Self-Starter: Inspired to perform without outside help
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
