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Compliance & Training Specialist is a member of the BioDlogics / Integra LifeSciences - Memphis Quality Department employed to ensure the Memphis site staff have been provided training to perform their job functions effectively and safely. Specialist, Compliance - Trainer will be responsible for creating and maintaining training files, ensuring the training files are current at all times, creating training content, delivering training content, ensure all competency reviews and testing are complete and filed, annual SOP reviews are performed, etc. Specialist, Compliance - Trainer will ensure a training is performed in full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB,  State Requirements and BioDlogics / Integra LifeSciences - Memphis Operating Procedures.

RESPONSIBILITIES

Design and maintain a comprehensive training programCreate and maintain training files for tissue bank staffEnsure all training files are in compliance at all times with SOPs, Regulations, and StandardsEnsure all training is documented and filed accordinglyEnsure all annual SOP reviews are prepared, performed, documented, and filed appropriatelyDevelop and deliver ongoing training content and presentationsPerform onboarding training as required and ensure all onboarding training is complete prior to the new employee’s date of hirePerform and/or ensure all initial competencies and annual competencies are performed, documented, and filedWork closely with Document Control to ensure all new and revised procedures, work instructions, forms, etc. are trained on in a timely mannerAll aspects of training position may be performed for Integra staff and outside agency staffMaintaining and providing donor and processing metrics to management.Track and trend metrics and prepare trends and graphs as directed by managementCreating/revising policies, procedures, specifications and formsServe as a project lead when required by managementMaintain up to date knowledge with respect to tissue banking activities performed at the siteAny 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 with 3+ years’ experience and at least 1 year of tissue/ocular donor record review experience.Knowledge of AATB Standards and FDA 21 CFR 1271 regulations.Preferably CTBS or CEBT certified.Earn CTBS Certification within first year of hire or as directed by supervisorExperienced and proficient with Excel, PowerPoint, and Word programs.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 playerAble to lift 40 lbs.

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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