Production Supervisor (Tissue Processing)

Work Shift: Saturday - Monday, 6 p.m. - 6:30 a.m.

Purpose

The Production Supervisor is responsible for serving as a subject matter expert for human tissue manufacturing while supervising employees and activities on the assigned production shift.

Responsibilities

•  Maintain a working knowledge and comprehensive understanding of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry standards
• Maintain competency in knowledge of aseptic technique and sterile fields
• Supervise production personnel and daily HCT/P production activities across morning, day, or night shift (as assigned), to include weekend overtime shifts when scheduled
• Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures
• Efficiently maximize manufacturing product yield based on established production plans
• Conduct and/or supervise execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, environmental monitoring and validation/qualification protocols.
• Accurately and concurrently document completion of manufacturing processes and support tasks on controlled records in accordance with good documentation practices (GDP), standard operating procedures, and regulatory requirements
• Serve as the shift liaison in the absence of the Production Manager
• Conduct and/or supervise sterilization of reusable supplies and related production support activities to ensure continuity of production activities
• Support risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated
• Identify and report occurrences of deviations/nonconformances to management and quality assurance
• Support deviation/nonconformance and CAPA investigations as a subject matter expert
• Complete self-administered read and understand training for standard operating procedures to ensure completion by assigned due dates
• Maintain training leadership communication and hands-on skills
• Conduct and/or supervise employee training in production procedures
• Author, revise, and maintain procedures in accordance with FDA, AATB, and other regulations (as appropriate)
• Work scheduled weekend shifts when required to support planned production or product development projects
• Provide business after-hours or on-call support remotely or on-site as needed for environmental monitoring alarms, personnel issues, and/or emergency events
• Develop and maintain relationships with key stakeholders, including vendors, customers, and employees
• Attend scheduled training sessions as needed to develop and maintain competency for assigned responsibilities and processes, which may be scheduled outside of the normal assigned work shift based on department needs
• Support routine production scheduling for assigned shift to meet production forecast.
• Manage direct reports
• Support establishment and monitoring of objective annual goals for direct reports
• Conduct performance reviews and support establishment of performance improvement plans as needed
• Support recruitment, interviews, and personnel selection for hire
• Report to work in-person and start job duties on time for established shift or for mandatory overtime on weekdays or during the weekend as scheduled
• Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly
• Attend all scheduled meetings and appointments
• Perform other duties as assigned

Skills

• Excellent attention to detail and organizational skills
• Effective verbal and written communication skills
• Self-motivated with the ability to work in a team environment and independently
• Experience working with Microsoft Office (Excel, PowerPoint, Word etc.)
• Excellent documentation accuracy
• Proficient in aseptic technique
• Demonstrated positive, optimistic, success-oriented attitude and ability to positively support the organization, applicable policies, and management decisions
• Ability to secure and maintain a favorable background investigation and clearance.
• Ability to push, pull or otherwise transport objects or materials weighing up to 25 lbs.
• Ability to perform job duties while seated or standing for 8-10 hours
  
  

Qualifications/Requirements

• High school degree or equivalent required
• Bachelor’s degree in a life science, certification in surgical technology (CST), Certified Tissue Bank Specialist (CTBS) (or related certification) preferred
• A minimum of 2-5 years of hands-on experience working in an aseptic or sterile environment (e.g., tissue processing, surgical technology, or a related field)
• A minimum of 2-5 years of experience working in an FDA-regulated environment for HCT/P manufacturing (or a related regulated industry such as pharmaceuticals, biotechnology, or medical devices)
• Valid Class “C” drivers license
• Successful completion of a favorable background investigation required