QC Analyst II/III-Histology

Role Summary

The QC Analyst II/III performs advanced quality activities in support of product production and releases with moderate/minimal supervision. This position interacts with internal departments including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics, and with external entities such as contractors and suppliers. The role conducts testing, trending, and reporting results to ensure compliance with regulatory requirements.

Responsibilities

• Primary responsibility for the day-to-day activities in the Histology laboratory in support of material and product release testing
• Morphological evaluation for release of final product and/or process development samples
• Scientific/technical contributor on cross-functional projects related to Histology activities and assay development/optimization
• Interact and coordinate with Manufacturing and QA Operations daily
• Tracking sample receipt
• Execute assigned tasks with minimal supervision
• Donated tissue receipt and transfer
• Identify and report areas for process improvement
• Generate and execute feasibility/validation protocols
• Generate trend reports as they relate to quality testing
• Work closely with team members to ensure timely release of materials
• Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations
• Assist with inter-departmental interactions to ensure customer service needs are satisfied and priorities understood
• Identify and implement issues and opportunities for improvements
• Revise/Create SOPs

Qualifications

• Minimum requirement; Bachelor’s Degree in a Life Science with 3-4 years of experience in a GMP/GLP regulated environment, ASCP Certified
• Utilizes advanced technology and scientific methods in the management of assigned technical specialization
• Advanced working knowledge of statistics; proficient in the use and application of quality tools, databases, and process skills
• Advanced knowledge of relevant Quality System and SOP procedures and industry regulations and standards (FDA, USP, ISO), with ability to interpret and apply quality and regulatory standards
• Utilizes advanced technology and scientific methods in the management of assigned technical specialization
• Advanced working knowledge of statistics; proficient in the use and application of quality tools, databases, and process skills
• Advanced working knowledge of tooling, test equipment, laboratory techniques, and CGMP

Skills

• Scientific and technical collaboration across cross-functional teams
• Laboratory testing, data analysis, and trend reporting
• Process improvement and quality systems familiarity

Education

• Bachelor’s Degree in Life Sciences or related field (required)

Additional Requirements

• Standing 2-3 hours per day with frequent stooping and lifting; repetitive hand movements (e.g., microtomy, biopsy punch, keyboard use)
• Flexibility to work some holidays and occasional 3rd shift to support critical final product release