Biotech and Pharmaceutical, Continuous Improvement, Cross-Functional, Data Management, Data Processing, Data Quality, Detail Oriented, Documentation, Documentation Review, GCP (Good Clinical Practices), GxP, Healthcare, Internal Audit, Laboratory Operations, Mentoring, Metrics, Product Support, Quality Assurance, Reconciliation, Regulatory Requirements, Systems Maintenance, Time Management
QA Specialist - Quality Data Reviewer
Location: Upper Merion (King of Prussia), PA
Schedule: Fully Onsite | Monday-Friday | Day Shift (8-hour schedule)
Pay Rate: $22.50 - $28.00 per hour
Alphanumeric is hiring a QA Specialist - Quality Data Reviewer to work onsite in Upper Merion (King of Prussia), PA with a global pharmaceutical organization dedicated to improving lives through innovative healthcare and medical advancements.
This role is ideal for a detail-oriented quality professional who thrives in a regulated laboratory environment and has a strong understanding of data integrity, cGxP requirements, and laboratory operations. The successful candidate will play a critical role in ensuring laboratory data is accurate, complete, compliant, and audit-ready while supporting product quality and batch release activities.
Responsibilities
- Review laboratory data and documentation to ensure accuracy, completeness, and compliance with internal procedures and regulatory requirements.
- Apply ALCOA+ data integrity principles during data review activities.
- Support timely batch release by ensuring quality review activities meet established turnaround times.
- Manage data lifecycle activities, including review, approval, reconciliation, and archiving of laboratory records.
- Identify opportunities to improve the efficiency and effectiveness of data review processes.
- Participate in internal audits, inspections, and compliance activities as required.
- Maintain tracking systems and review metrics to provide visibility into progress, priorities, and outstanding items.
- Collaborate with laboratory, quality, and cross-functional stakeholders to align on timelines and quality expectations.
- Assist with training and mentoring team members on quality processes and data review requirements.
- Participate in team meetings and provide updates, insights, and recommendations to support continuous improvement initiatives.
- Ensure all reviewed documentation meets internal and external standards for accuracy, clarity, and completeness.
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Alphanumeric Systems Inc