Shift: Production Technician I (Saturday through Monday: 6 AM to 6:30 PM)

Purpose:

The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and support processes to execute and support the production schedule.

Duties & Responsibilities:

• Develop and maintain a working knowledge of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry standards.
• Develop and maintain competency in knowledge of aseptic technique and sterile fields.
• Complete self-administered read and understand training for standard operating procedures to ensure completion by assigned due dates.
• Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures.
• Use good judgement to maximize manufacturing product yield based on established production plans.
• Support execution of cleanroom/equipment cleaning, decontamination, maintenance, calibration, and environmental monitoring.
• Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with standard operating procedures.
• 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.
• Identify and report occurrences of deviations/nonconformances to management and quality assurance.
• 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.
• 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 administrative or related duties as assigned.

Skills & Abilities:

• Attention to detail and organizational skills.
• Self-motivated.
• Effective verbal and written communication skills.
• Ability to work in a team environment and independently.
• Experience working with Microsoft Office (Excel, PowerPoint, Word etc.)
• Ability to secure and maintain a favorable background investigation and clearance.

Physical Requirements:

• Ability to work seated or standing for 8-10 hours.
• Ability to push, pull or otherwise transport objects or materials weighing up to 25 lbs.
• Ability to document work with accurately and with legible handwriting.

Education:

• High school diploma or equivalent.
• Associate degree in a life science or certification in surgical technology (CST) (or related certification) preferred.
• At least 6 months of hands-on experience with aseptic technique required.
• At least 1 year of experience in an FDA regulated environment preferred.