Document Control Specialist

Job Description

Job Description

Description :

AVITA Medical is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration.

Our FDA-approved RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patients’ own skin to create Spray-On Skin cells.

We believe that patients are at the heart of everything we do, our employees are the lifeblood of AVITA Medical, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.

Position Summary :

Coordinates, implements, and maintains AVITA Medical’s Training System in QT9, AVITA’s electronic Quality Management System (eQMS).

Follows established procedures and policies to meet the demands of training requirements in a regulated medical device company.

Maintains activities for employee training assignments per established procedures to support effective training compliance.

Key Responsibilities :

• Responsible for the execution of the QMS training and change control processes within the company
• Supports Quality System training and change control processes
• Facilitates training assignments for new and existing employees
• Responsible for new employee QMS training
• Creates and maintains training records in QT9 (electronic and hard copy as applicable)
• Provides support for users of QT9 Training Modules
• Supports Document Control as required within the company.
• Responsible for coordinating engineering changes, including review, approval, and retention of documentation in support of effective change control
• Works with Quality Team to identify continuous improvement opportunities and streamline processes
• Other duties as assigned by the Manager in support of training and change control responsibilities
• Travel to Valencia office 20% of the time

Requirements :

• Prefer Bachelor of Science or equivalent with 3-5 years’ experience in training and documentation control systems, with preference in coordination and administration of systems within FDA QSR / ISO requirements.
• Experienced in formatting Microsoft Word documents
• Must have great attention to detail
• Excellent customer service and Teamwork skills
• Proficient in communication and working with teams that consist of diverse personnel at various levels and locations.
• Works well under pressure with changing priorities and deadlines
• Must be organized and able to complete multiple tasks during the workday
• Advanced English language skills : writing, grammar, proofreading & redlining
• Full understanding of documentation control systems within a medical device company certified to ISO Standards and FDA QSR

EEOC : AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All employment decisions are based on qualifications, merit, and business needs.

Your Physical Work Environment Will Require : The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and / or balance, use hands and fingers to type, handle, feel, grasp, push, and pull.

Hand-eye coordination is necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus.

The individual is frequently required to reach with hands and arms, and repetitive motion, The individual is occasionally required to stoop, kneel, or crouch.

The individual may occasionally lift and / or move up to 25 pounds.

AVITA Medical is an E-Verify participant.

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner.

AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.