Quality Control Specialist

at  Integra LifeSciences

Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This role will be 2nd Shift Position: Wednesday to Sunday from 2pm - 10:30 pm
Job Description
Specialist, Quality Control is a member of the BioDlogics / Integra LifeSciences - Memphis Quality Department employed to ensure all human tissue, supplies, reagents, materials, etc. are inspected and approved for use prior to receipt and throughout key steps during the process. Specialist, Quality Control will be responsible for performing inspections of incoming donor tissue, supplies, materials, and reagents, will control tissue while stored in Quarantine, ensure all required in-processed testing is performed and acceptable, ensure labeling and packaging is correct prior to release of product to finished goods. Specialist, Quality Control will be responsible for ensuring BioDlogics / Integra LifeSciences – Memphis’ tissue and final tissue products are released in a timely and efficient manner. Specialist, Quality Control will ensure full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB, ISO 13485, State Requirements and BioDlogics / Integra LifeSciences - Memphis Operating Procedures.

Job Responsibilities

• Inspect and approve human tissue, materials, reagents, and supplies.
• Create, maintain, and inspect to Material and Tissue Specification Sheets.
• Ensure all received and approved human tissue, materials, reagents, and supplies are from approved suppliers.
• Ensure all tissue remains in quarantine until released appropriately and is stored in a manner that keeps tissue separated and segregated and in approved order for easy identification and pulling for processing, labeling, etc.
• Receive and review all required in-process testing results.
• Perform Environmental Monitoring/Personnel Monitoring. Review and document results. Log information into appropriate database.
• Perform Temperature Monitoring. Review and document results. Log information into appropriate database.
• Perform pre- and post-sterilization Tissue Product Inspections and compare against the Product Specification Sheets to ensure compliance.
• Perform inspections at each step of the final labeling and packaging process and ensure documentation is complete and accurate.
• Obtain Tissue Retain Sample(s) for each final lot from distribution team and place in the appropriate area in the Tissue Retain Sample Storage Area. Ensure documentation is complete and accurate.
• Complete all documentation prior to submitting to QA.
• Perform all inspections needed to ensure tissue is properly distributed.
• Ensure work orders and other information needed for billing/payments from QC are completed in real time and accurately.
• Log donors into all applicable databases. All databases/logs MUST be current at all times.
• Prepare trends and graphs.
• Maintaining and provide quality control related metrics to management.
• Assist in creating/revising policies, procedures, specifications and forms for the Quality Control department.
• Any other duties or responsibilities necessary or as assigned.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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• Inspect and approve human tissue, materials, reagents, and supplies.
• Create, maintain, and inspect to Material and Tissue Specification Sheets.
• Ensure all received and approved human tissue, materials, reagents, and supplies are from approved suppliers.
• Ensure all tissue remains in quarantine until released appropriately and is stored in a manner that keeps tissue separated and segregated and in approved order for easy identification and pulling for processing, labeling, etc.
• Receive and review all required in-process testing results.
• Perform Environmental Monitoring/Personnel Monitoring. Review and document results. Log information into appropriate database.
• Perform Temperature Monitoring. Review and document results. Log information into appropriate database.
• Perform pre- and post-sterilization Tissue Product Inspections and compare against the Product Specification Sheets to ensure compliance.
• Perform inspections at each step of the final labeling and packaging process and ensure documentation is complete and accurate.
• Obtain Tissue Retain Sample(s) for each final lot from distribution team and place in the appropriate area in the Tissue Retain Sample Storage Area. Ensure documentation is complete and accurate.
• Complete all documentation prior to submitting to QA.
• Perform all inspections needed to ensure tissue is properly distributed.
• Ensure work orders and other information needed for billing/payments from QC are completed in real time and accurately.
• Log donors into all applicable databases. All databases/logs MUST be current at all times.
• Prepare trends and graphs.
• Maintaining and provide quality control related metrics to management.
• Assist in creating/revising policies, procedures, specifications and forms for the Quality Control department.
• Any other duties or responsibilities necessary or as assigned