- Train and assist processing or other associates in regard to Quality System process and documentation execution as well as other procedures and systems as assigned or determined.
- Review, process and provide feedback to associates on submissions to the Quality Systems, such as document initiation or changes, document training, or other submissions as assigned.
- Coordinating document control reviews with process owners and customers, as applicable.
- Assist new product development with implementation of controlled documents to ensure timely execution of new products and processes.
- Prioritize, monitor and control documents associated with projects, process improvements, new product development.
- Assist in the approval, release and control of Product related labeling.
- Assist with the quality inspection of returned material authorization (RMA) product and documentation, as needed.
- Collaborate with cross functional Teams to train or participate in business continuity functions, and other tasks as assigned by Leadership.
- Assist in other Quality system functions, as assigned.
- Associate's Degree preferred, not required.
- High School diploma required.
- 2 Years of quality experience in a health-related field required.
- Knowledge of FDA/ISO regulations associated with processing and manufacturing of HCT/Ps and Medical Devices and/or Biologics is preferred.
- Experience in medical device, pharmaceutical, or HCT/P processing or blood banking is preferred.
- Develop skills and in-depth knowledge of processing practices by means of interaction in Review Boards to assist in the processing of quality related documentation.
- Develop in-depth knowledge of industry and Regulatory Quality Best Practices and Process Monitoring under the guidance of Quality and Regulatory Leadership; implementing these through completion of assigned tasks and investigations.
- Quality & Regulatory Leadership. You will have daily verbal and written communication with your Leadership to ensure assigned tasks are completed per schedule or Regulatory requirements.
- Your Supervisor. You will maintain daily communication with Quality Leadership providing assignment status and processing observations as determined by your Supervisor.
- 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 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
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Document Control Specialist - Phoenix, United States - Pinnacle Transplant Techn
Description
Job Description
Job DescriptionAbout 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).
How You Contribute to Pinnacle Transplant's Success
You are Pinnacle's front line. You manage and oversee the document control system and other quality systems, as assigned, to ensure accurate manufacturing of donated human tissue into high-precision product for use as surgical implants. You have direct ownership of the quality assurance systems and their compliant implementation.
What You Will Do
What Qualifications You Will Bring
How You Will Grow
Who You Will Partner With
Where You Will Work
You will work in an office setting, in a manufacturing facility in North Phoenix, having potential contact with human tissue and bone. You may be required to wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls as determined by the area in which tasks require you to be present.
Benefits: Company benefits package includes:
Paid Time Off:
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