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.