Document Control Specialist I

Benefits:

• Medical - Dental - Vision
• Generous PTO Schedule
• Corporate Gym Discount
• 401(k)
• Well-Being Programs / LifeBalance Discount Program
• Life & AD&D Life Insurance
• Long-Term & Short-Term Disability
• Tax Savings
• Wellness Apps (Calm & Burnalong)
• And more...

A. Responsibilities of the Document Control Specialist I:

• Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
• Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
• Develop and maintain an understanding of the Xtant Medical products and general biological and chemical systems utilized within the Department.   Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
• Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
• Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
• Represent the company in a professional manner to the public, customers, and vendors, and maintain trusting relationships with physician partners, customers, and fellow employees
• Support VP, QA/RA and QMS Manager in any and all ways as needed
• Help prepare for and participate in external audits with clients and/or government regulatory inspections (FDA inspectors, ISO inspectors, etc)
• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required
• Participate in projects where changes to documents may be required as part of changes to, improvements to, and/or the launch of new products and processes
• Maintenance of Xtant Medical’s Document Control and Record Control systems to meet the needs of the company and ensuring the integrity of the systems both in hard copy (paper) and electronic formats
• Develop and maintain an understanding of how the Document Control system interacts with all of the activities performed by the various departments of the company. Understand how the flow of document revisions affects the departments and their ability to function
• Maintains document reference libraries and databases. This includes but is not limited to Document Control, Records, and External Standards
• Assist in the timely and efficient completion and retention of documentation. This includes all aspects of Change Order assignment, creation, producing hard copy materials for approval signatures, finalization of documents, creating compare-result documents, and making documents effective
• Send notification to all affected departments when document revisions and/or new documents are made effective
• Maintains the Change Order Log, Change Requests, and Records to ensure continued accuracy and traceability of documents and records, document revisions, assignment of new document numbers, current status of documents, and documentation of approvals
• Request retrieval of documents from off-site storage as needed
• Ongoing maintenance and filing of training documents in individual training files for all personnel of the QA/QC, Regulatory Affairs, and other departments as assigned
• Responsible for the scanning, filing, and archiving of training files for all technical staff resources no longer in employment with the organization
• Responsible for filing other documents as requested
• Responsible for saving documents electronically as requested
• Other duties as assigned

B. Education/Credentials, Experience & Training

• High School Diploma or General Education Degree Required
• One (1) year experience directly related to the duties and responsibilities          listed above preferred

C. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Must be able to reason independently
• Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
• Must be able to adapt to quickly changing priorities and schedules
• Ability to maintain good working relationships with all co-workers and use good judgment in recognizing scope and authority

D. Working Conditions

• Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work
• Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
• Work will require long periods of sitting, standing, and working at a computer
• Duties may include contact with human tissue, blood, bone, and fluids 

E. Health and Safety

• Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
• This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves
• Will require experience or training in the routine handling of chemicals and biohazards
• May require OSHA (bloodborne pathogen) training, MSDS/SDS, and other safety training as applicable
• Must be able to lift 60 lbs.

Note:

This position does not offer current or future H-1B Visa Sponsorship.