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QA Specialist – Quality Data Reviewer

Alphanumeric Systems, Inc.

King of Prussia, PA

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JOB DETAILS
SALARY
$22.50–$28 Per Hour
SKILLS
Analysis Skills, Biochemistry, Biological Assay, Biology, Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Cross-Functional, Data Management, Data Processing, Data Quality, Detail Oriented, Documentation, Documentation Review, Establish Priorities, GCP (Good Clinical Practices), GxP, Healthcare, High Performance Liquid Chromatography (HPLC), Immunoassays, Internal Audit, Laboratory Operations, Leadership, Mentoring, Metrics, Microbiology, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Support, Quality Assurance, Real-time PCR (qPCR), Reconciliation, Regulations, Regulatory Requirements, SAP ECC (fka SAP R/3 and SAP ERP), Systems Maintenance, Team Player, Test Lab, Time Management, Writing Skills
LOCATION
King of Prussia, PA
POSTED
3 days ago

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.


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.

About the Company

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Alphanumeric Systems, Inc.