Document Control Specialist I

At Xtant Medical, our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full-time, non-exempt Document Control Specialist I to join our team on-site in Belgrade, MT. It offers a pay rate of $50,000-$56,000.00 and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you've found the right place at Xtant Medical!

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:

This position ensures ongoing maintenance and control of the company's Quality Management System controlled documents and records. This position interacts with employees throughout the company and with other divisions of the company.

This position reports to the QMS Manager. This position may provide additional support to other supervisors, managers, or departments as requested. This position is responsible for communicating effectively with other individuals within all departments.

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 Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

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

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.