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).
How You Contribute to Pinnacle Transplant’s Success
The Sterility Assurance Technician is part of the Quality Assurance team working on utilizing the gift of human tissue to address various unmet clinical needs through innovative regenerative medicine products to improve the quality of life of patients. The Sterility Assurance Technician's primary role will be coordinating environmental monitoring activities, data analysis, data entry, and trending as it pertains to sterility assurance.Work hours: Monday - Friday, 8:00 am - 5:00 pmWork environment: Wet lab environment in a manufacturing cleanroom facilityLocation:
North Phoenix, near 19th Avenue and Pinnacle Peak Road
Pay Rate: $21.00-$25.00 (dependent on experience)
What You Will Do, Essential Duties and Responsibilities
- Perform environmental monitoring sampling (surface plating, viable and non-viable air monitoring, personnel monitoring).
- Assist/Perform testing incoming reagents, sample tracking, results tracking, sample data entry, and inventory.
- Assemble, ship, and track sample submission and documentation.
- Assist upkeep and accuracy of sample submissions.
- Document legibly and concurrently.
- Follow testing schedules.
- Receive and distribute testing samples to third party laboratories.
- Assist in maintaining the quality and timeliness of sample testing orders from delivery to results.
- Assist in investigations related to Environmental Monitoring Excursion reports.
- Assist with execution of the Dose Audits.
- Manage, generate, and organize environmental monitoring and bioburden reports and data which directly feed into the quality system.
- Provide microbiological testing support for validation activities (facilities, manufacturing, and engineering).
- Assist in maintaining and developing SOPs regarding microbiological quality and sterility assurance.
- Assist with schedule with outside laboratories and sterilization contractors sample processing and testing to support laboratory and/or sterilization programs.
- Contributes to the completion of routine technical tasks and microbiological testing.
- Other duties as assigned by the Supervisor and/or PTT Leadership.
What Qualifications You Will Bring, Education and Work Experience Requirements
- Bachelor’s degree in microbiology, biological sciences or related field is strongly preferred.
- 1-2 years laboratory experience using aseptic technique preferred.
- Previous Environmental Monitoring and Microbiological Testing experience is preferred.
- Working knowledge of common human skin flora and disinfection methods.
- Knowledge of mycoplasma, endotoxin and sterility testing of human cells and tissues.
- Basic skills in Microsoft Office Products, primarily Excel.
Who You Partner With, Key Interactions & Relationships
- Daily face to face and written communication with R&D, Sterility Assurance personnel and Supervisor to ensure tasks are executed appropriately.
- Daily Interaction with Production, Validation and Engineering team to obtain samples for testing, assist in sample submission.
- Regular interaction with Production to determine appropriate actions to take in relation to Environmental Monitoring Excursion report.
- Collaboration with other departments including Quality Assurance/Control, Production, and Regulatory Affairs as needed and assigned by Supervisor to support sterility assurance and environmental monitoring activities.
Benefits/Total Rewards
:
- 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, and 100% Vested from the start of plan.
- Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, Hospital Indemnity, 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
21 To 25 (USD) Hourly
