QA Specialist � Quality Data Reviewer
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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
- 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
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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
