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Form of work*This is a 3rd shift position. Sunday - Thursday, 10:30 pm - 7am*
JOB DESCRIPTION
Quality Control (QC) Specialist - Inspection and Testing is a member of the 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. QC Specialist - Inspection & Testing 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. QC Specialist - Inspection & Testing will be responsible for ensuring our tissue and final tissue products are released in a timely and efficient manner. QC Specialist - Inspection & Testing will ensure full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB, ISO 13485, State Requirements and Standard Operating Procedures.
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.
REQUIRED SKILLS & KNOWLEDGE
BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) or equivalent education/experience with at least 1 year of Quality Control or a High School diploma with at least 4 years of experience in Quality Control.
Previous Quality Control inspection experience in an FDA regulated field, preferred.
Knowledge of AATB Standards and 21 CFR 1271 regulations, preferred.
AATB CTBS Certification, preferred.
Experienced and proficient with Microsoft Office Suite.
Organized, attention to detail and maintain appropriate analytical skills.
Experience in applying statistical methods for quality improvements.
Organized file management.
Strong communication skills, both written and verbal.
Professional team player
Able to lift 40 lbs.
JOB DESCRIPTION
Quality Control (QC) Specialist - Inspection and Testing is a member of the 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. QC Specialist - Inspection & Testing 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. QC Specialist - Inspection & Testing will be responsible for ensuring our tissue and final tissue products are released in a timely and efficient manner. QC Specialist - Inspection & Testing will ensure full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB, ISO 13485, State Requirements and Standard Operating Procedures.
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.
REQUIRED SKILLS & KNOWLEDGE
BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) or equivalent education/experience with at least 1 year of Quality Control or a High School diploma with at least 4 years of experience in Quality Control.
Previous Quality Control inspection experience in an FDA regulated field, preferred.
Knowledge of AATB Standards and 21 CFR 1271 regulations, preferred.
AATB CTBS Certification, preferred.
Experienced and proficient with Microsoft Office Suite.
Organized, attention to detail and maintain appropriate analytical skills.
Experience in applying statistical methods for quality improvements.
Organized file management.
Strong communication skills, both written and verbal.
Professional team player
Able to lift 40 lbs.
