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.

Job Requirements

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Microbiology, or a related scientific discipline OR equivalent industry experience.
• Minimum of 2 years of pharmaceutical, biotechnology, laboratory, or quality-related experience preferred.
• Strong attention to detail and ability to manage high volumes of data review activities.
• Understanding of cGxP regulations, data integrity requirements, and ALCOA principles.
• Experience working within regulated laboratory environments.
• Strong organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and effectively with minimal supervision.
• Proficiency with Microsoft Excel, Word, and PowerPoint.

Preferred Qualifications

Experience with laboratory systems such as:

• SAP / ERP
• LES (Laboratory Execution Systems)
• WebStatistica
• Empower
• Hamilton

Experience supporting analytical testing and laboratory operations, including:

• Separations: HPLC, CGE, CE-SDS, cIEF
• Immunoassays: ELISA, qPCR, SPR, Bioassays
• Compendial Testing
• Microbiology: Bioburden, Endotoxin

What We're Looking For

• Exceptional attention to detail
• Strong data review and data integrity mindset
• Ability to prioritize multiple tasks and meet deadlines
• Collaborative team player with leadership potential
• Commitment to quality, compliance, and continuous improvement

If you're passionate about quality, data integrity, and supporting life-changing pharmaceutical products, we'd love to hear from you.