Compliance & Training Specialist

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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 program

• Create and maintain training files for tissue bank staff

• Ensure all training files are in compliance at all times with SOPs, Regulations, and Standards

• Ensure all training is documented and filed accordingly

• Ensure all annual SOP reviews are prepared, performed, documented, and filed appropriately

• Develop and deliver ongoing training content and presentations

• Perform onboarding training as required and ensure all onboarding training is complete prior to the new employee's date of hire

• Perform and/or ensure all initial competencies and annual competencies are performed, documented, and filed

• Work closely with Document Control to ensure all new and revised procedures, work instructions, forms, etc. are trained on in a timely manner

• All aspects of training position may be performed for Integra staff and outside agency staff

• Maintaining and providing donor and processing metrics to management.

• Track and trend metrics and prepare trends and graphs as directed by management

• Creating/revising policies, procedures, specifications and forms

• Serve as a project lead when required by management

• Maintain up to date knowledge with respect to tissue banking activities performed at the site

• 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 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 supervisor

• Experienced 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 player

• Able 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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