The Production Supervisor I is responsible for planning, directing, and coordinating the work of assigned production staff engaged in manufacturing cadaveric derived orthopedic 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 I 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.
Key Interactions & Relationships
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 Production to ensure business demands are met.
Essential Duties and Responsibilities
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 Core Area 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 Director of Production and/or PTT leadership that may include process improvement projects and training curricula development.
Knowledge, Skills, and Abilities Required
Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Personnel Management — Motivating, developing, and directing people as they work and identifying the best people for the job.
Training — Knowledge of principles and methods for teaching and instruction for individuals and groups, and the measurement of training effects.
Production and Processing — Knowledge of materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of products.
Manual Dexterity — The ability to quickly move the hand, the hand together with the arm, or two hands to grasp or manipulate objects.
Arm-Hand Steadiness — The ability to keep the hand and arm steady while moving or while holding the arm and hand in one position.
Near Vision — The ability to see details at close range (within a few feet of the observer).
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.
Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
Critical Thinking — The ability to analyze and evaluate information gathered from, or generated by, observation, experience, reflection, reasoning, or communication in order to form a judgment.
Problem Sensitivity and Problem Solving— The ability to tell when something is wrong or is likely to go wrong and taking action to prevent or solve the problem.
Operation and Control — Controlling operations of equipment or systems.
Quality Control Analysis — Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Troubleshooting — Determining causes of operating errors and deciding what to do about it.
Time Management — Managing one's own time and the time of others.
Physical Environment & Working Conditions
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.
Equipment & Machines Used
Autoclave, heat sealer, sonicator, Lyophilizer, TMI grinder, centrifuge, and other production equipment
Desktop computer and general office equipment.
Education and Work Experience Requirements
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 required.
Experience in all levels of manufacturing states including freeze drying, sterilization, DBM, and packaging, is preferred.
Must become a Certified Tissue Banking Specialist within two years of hire or promotion to the position.
Internal Number: 001
About Pinnacle Transplant Technologies
Founded in 2010, Pinnacle Transplant Technologies (PTT) recognized the need to establish a processing and distribution facility that would enable medical professionals to acquire safe quality allograft tissue for transplant. The company manufactures innovative allografts produced to the highest standards of quality and safety. With a dedication to customer service, we are devoted to being the most responsive and accommodating Tissue Bank in the industry. Learn more about our specific products.
Pinnacle Transplant Technologies is a multi-service tissue bank dedicated to the ethical participation in the Donate Life ™ process. U.S. Food and Drug Administration (FDA) registered and American Association of Tissue Banks (AATB) accredited, Pinnacle only works with federally chartered Organ Procurement Organizations (OPOs) and agencies accredited by AATB to help provide superior allografts for transplantation, assure transplant patient safety, safeguard our associates, and assure reverence to our donor families.