Document Control Specialist

About Us

Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

The Purchasing Associate position is a full-time-in-person position, located in North Phoenix (101 & 19th Ave). Hourly wages are $23.00 - $27.00 dependent upon experience.

How You Contribute to Pinnacle Transplant’s Success

The Document Control Specialist is responsible for compiling, classifying, storing and maintaining all controlled documentation related to the origin, production, and distribution of human tissue allografts for use by surgeons in implantation procedures. He/she is responsible for clerical duties related to the maintenance of controlled documentation and completes tracking, logging, updating and version control of technical documents according to FDA, AATB, OSHA, cGTP and business standards.

In addition, the Document Control Specialist is responsible for coordinating and conducting all training programs.

What You Will Do

• Comply with FDA, AATB, OSHA, cGTP, state rules and regulations, and PTT SOPs at all times.
• Complete work assignments to meet department goals and keep supervisor informed of work progress and issues.
• Serve as subject matter expert for Document Control System ensuring traceability of documentation throughout the product's entire life cycle
• Assist with data entry, analysis, and document administration.
• Provide metrics for the Document Control system, as requested.
• Process and monitoring document change requests in accordance with DCR program.
• Responsible for checking incoming documentation for accuracy, related to document formatting and version control.
• Scan or read incoming materials to determine how they should be classified and where they should be filed.
• Sort or classify information according to content, purpose, and retrieval criteria for chronological, alphabetical, or numerical order in accordance with PTT processes and procedures.
• Input data, such as file numbers, new or updated information, or document information codes into applicable systems to support document and information retrieval.
• Perform general office activities, such as word processing, answering telephones, operating office machines, and securing confidential materials.
• Set up and send reminders of due dates for file completion; Route paperwork for file completion.
• Create and work with electronic files for the appropriate systems as needed.
• Acknowledge and answer customers in a timely and professional manner as needed.
• Maintain current knowledge of software features and maintain proficiency in using PTT’s computer and communications systems.
• Provide quality system data for analysis and management reviews as requested.
• May assist in performing support functions during Customer, AATB and FDA audits to include supplying and retrieving requested documentation.
• Assist supervisor in completing administrative tasks as assigned.
• Assists supervisor in completing administrative tasks as assigned.
• Complete training and re-training in work and safety procedures no less than once each year.
• Maintain and advance technical skills through professional training and education.
• Cross-train in critical functions and assist in other departments as assigned.
• Interact with other departments to fulfill deliverables for changes to system processes. Maintain updated curriculum database and training records.
• Manage and maintain in-house training facilities and equipment.
• Other duties as assigned by Manager/PTT Leadership including content development, training material creation including creating training folders, forms etc. data entry and filing.
• Other duties as assigned by the Supervisor and or PTT Leadership that may include training material creation including creating training folders, forms etc. data entry and filing and other assigned administrative duties.

Who You Will Partner With

• Daily written and verbal communication with Supervisor to ensure all duties are understood and executed in a timely manner.
• Regular communication with various internal departments to ensure documents are updated and all Document Change Requests are released in a timely manner.
• Regular written and verbal communication with the Managers of each department to ensure all training pertaining to their associates are revised and adhere to department specific policies and procedures.
• Regular verbal and written communication with appropriate staff including supervisors, managers and subject matter experts to collect and share information as it relates to training design, implementation and facilitation as well communication regarding the effectiveness of training individual and individual associate growth.

What Qualifications You Will Bring

• High School Diploma, GED or equivalent is required
• Working knowledge of computer systems such as Excel and Microsoft Office Products
• Minimum of 1 year experience in Quality Systems in an FDA regulated industry

What Qualifications Would be Additionally Helpful

• Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology. Proficiency in Microsoft Office, specifically WORD, Excel and PowerPoint.
• Organization- Excellent documentation, organization and follow-up skills, should have the ability to reorganize and reschedule work on short notice in order to meet revised deadlines or company needs.
• Service Orientation — Actively looking for ways to help people.
• Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong.
• Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
• Perceptual Speed — The ability to quickly and accurately compare similarities and differences among sets of letters, numbers, objects, pictures, or patterns. The things to be compared may be presented at the same time or one after the other. This ability also includes comparing a presented object with a remembered object.
• Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Oral and Written Communications — Conveying information and ideas so others will understand.
• Establishing and Maintaining Interpersonal Relationships — The ability to develop constructive and cooperative working relationships with others, and to maintain them over time.

Where You Will Work

• Full Time position (40 hours or more) based in Arizona. Hours may include evenings and weekends to perform tasks outlined in the job description.

• The Document Control Specialist may work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required.

Benefits:Company benefits package includes:

• Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date
• Company-Paid Short and Long-term Disability Insurance
• Company-Paid Identity Theft Protection
• Company-Paid Life Insurance Policy of $50,000
• 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment.
• Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance

Paid Time Off:

• Paid time off given at the increments below:
  • January 1st 40 hours
  • April 1st 30 hours
  • July 1st 30 hours
  • October 1st 20 hours
• (1) week paid sick time, accrued per pay period beginning after 90-days of employment
• (10) annual paid holidays