QA Specialist

• 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.

• 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.

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!