QA Specialist

Alphanumeric is hiring a QA SPECIALIST to work in Upper Merion, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. Pay Range: $22.50 - $28.00 Quality Data Reviewer will: Ensure all data reviewed is accurate, complete, and compliant with internal procedures and regulatory requirements. Participate in audits and inspections as needed, providing accurate and thorough documentation to support compliance efforts. Identify opportunities to improve the efficiency and accuracy of the data review process. Manage the process of data lifecycle activities, including review, approval, and archiving of laboratory records. Communicate effectively with stakeholders to ensure alignment on priorities and timelines. Continuously expand knowledge of quality systems, data review tools, and product-specific requirements. Regularly update tracking tools or systems to provide visibility into review progress and outstanding items. Actively participate in team meetings, providing updates on progress and sharing insights to improve overall performance. Ensure all documentation reviewed meets internal and external standards for accuracy, completeness, and clarity. Requirements: Bachelors Degree or 2 years of industry experience - Area of specialization in Biology, Biochemistry, Microbiology or equivalent technical discipline. There is a high volume of data that requires a thorough review using ALCOA principles, attention to detail, meeting turn around times for batch release, adhering to procedures, training others and work with minimal supervision. Experience with laboratory functionality and technical understanding of analytical assays is necessary to execute job functions. Attention to detail. Working knowledge of cGXP, Data integrity, ALCOA principles. System experience preferred- SAP/ERP, LES, Webstatistica, Empower, Hamilton. Analytical experience preferred (e.g. Separations- such as CGE/CE-SDS/HPLC/cIEF, Immunoassay- ELISA/qPCR/SPR/Bioassay, Compendia and/or Microbiology-Bioburden/Endotoxin). Experience using Excel, Word and Powerpoint. Strong organizational and task management skills. Strong leadership skills. Strong data analysis, data trending and communication skills. Ability to work independently or as part of a team with minimal supervision. #J-18808-Ljbffr