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 Production Supervisor is responsible for planning, directing, and coordinating the work of assigned production staff engaged in manufacturing birth tissue and other specialty tissue allografts for the biomedical industry and related activities such as cleaning and disinfecting cleanrooms, decontaminating instruments, and ensuring the readiness of all tissues, instrument carts etc. The Production Supervisor is responsible for the smooth running of all assigned production teams and the quality of output.
She/he will be responsible for ensuring the manufacturing processes are conducted in an efficient and productive manner and in accordance with customer requirements and with company SOPs, AATB standards, and federal and state government rules and regulations.
What You Will Do
- Accomplish production team results by communicating job expectations; planning, monitoring, and appraising job results; coaching, and counseling associates; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
- Supervise Clean Room Areas ensuring proper protocols are being followed at all times, ensuring audit readiness within the specified departments and report needs to Manager accordingly.
- Coordinate and plan the use of the cleanrooms and issue work assignments to meet production goals and keep Management informed of progress.
- Evaluate individual performance and provide mentoring and discipline to direct reports.
- Interview job applicants and make recommendations regarding hiring of new associates.
- Interpret company policies and procedures for associates.
- Responsible for training team members in accordance with work procedures and SOP’s to ensure processes are completed in compliance with company, AATB, FDA and other applicable standards.
- Inspect cleanrooms, instrument carts, equipment, and materials to ensure compliance with standards.
- Investigate complaints about service and equipment, and take corrective action.
- Responsible for maintaining time keeping system, monitoring associates' attendance and hours worked.
- Ensure Good Documentation Practices and SOP’s are being followed at all time in accordance with PTT processes and regulatory standards.
- Responsible for the ensuring daily production occurs according to planning and direction from Management.
- Responsible for administrative tasks to include but not limited to writing SOP’s, Deviations, WIP Inventory Log, Change Control Processes and Chart Review.
- Monitor compliance with FDA, AATB, and state rules and regulations and PTT policies and procedures at all times and notify Director of Operations and/or Quality Control Manager of any procedural deviations.
- Confer with Quality Systems staff to ensure that safety procedures are followed at all times.
- Collaborate with supervisors and staff to recommend process improvements and to update SOPs.
- Ensure proper levels of Personal Protective Equipment (PPE) are maintained in locker rooms, clean rooms, and the General Laboratory Area.
- Ensure proper levels of cleanroom supplies are maintained to support production and communicate inventory levels to Shipping and Receiving.
- Complete required training and re-training in work and safety procedures no less than once each year.
- Other duties as defined by PTT leadership that may include process improvement projects and training curricula development.
What Qualifications You Will Bring
- Bachelor’s degree in a related field is preferred.
- A minimum of 3 years as an individual contributor working in a regulated industry or manufacturing role using aseptic technique with a minimum of 1 year in a supervisory role is preferred.
- Experience in all levels of manufacturing states including blunt tissue dissection, sterilization/cleaning, and packaging, is preferred
How You Will Grow
- Develop skills in all areas of manufacturing stages including freeze-drying, sterilization, packaging and other areas of production.
Who You Will Partner With
- Responsible for the daily direction of assigned reports to ensure Production is executed in efficient and productive manner and in accordance with applicable policies and regulations.
- Interaction with cross-functional internal teams, including Regulatory Affairs/Quality Assurance (RA/QA), to ensure production demands are met and in accordance with applicable regulations.
- Face to face and written communication with Production Manager and Director of Operations to ensure business demands are met.
Additional Desired Qualifications
- Prior leadership experience with a team of 5+, preferred
- Ability to follow regulatory requirements
- Player/Coach mentality – ability to lead/coach a team, also the ability to learn and complete the work with the team. No job is too small.
- Ability to work through heavy documentation and work instructions
- Ability to partner with multiple departments and multiple leaders to ensure team is setup for success
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.
- Duties are such that there will be contact with human tissue and bone which may be considered infectious; use of PPE is required in all work areas.
- Duties are such there will be regular use of reagents in a controlled environment, use of PPE and adherence to safety data sheets is required.
- Position works in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required.
- Work requires standing for long periods of time. Exertion of up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
- Work requires repetitive motion; substantial movements (motions) of the wrists, hands, and/or fingers.
- Include special considerations for the position, such as occasional travel or necessary overtime.
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
- Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance
Paid Time Off:
- (4) weeks paid vacation, prorated based on quarter hired
- (1) week paid sick time, accrued per pay period beginning after 90-days of employment
- (10) annual paid holidays
Schedule: Shift B -Monday - Thursday - 3pm - 1:30a.m.
78000.00 To 78000.00 (USD) Annually
