Production Technician IBRAVO SHIFT: TUESDAY - FRIDAY 3:30PM - 2:00AM
Pay: $21.49/Hourly with 15% Shift Differential
PurposeThe Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and related support processes to execute and sustain the production schedule. This role requires strict adherence to FDA regulations, industry standards, and Good Manufacturing Practices (GMP).
Responsibilities:- Complete assigned training on standard operating procedures (SOPs) by required deadlines
- Maintain competency in aseptic technique and sterile field protocols through ongoing training
- Manufacture finished products from human tissue using aseptic technique in compliance with SOPsApply good judgment to optimize tissue processing efficiency and maximize product yield
- Identify and report deviations and nonconformances to management and Quality Assurance
- Perform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoring
- Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with SOPsAccurately and concurrently document manufacturing processes and support tasks in controlled records
- Ensure all documentation complies with GDP, SOPs, and regulatory requirements
- Report to work on-site and on time for scheduled shifts, including mandatory overtime when required
- Attend all scheduled meetings, training sessions, and appointments as assigned
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
Perform other duties as assigned
SkillsAbility to work independently and in a team environment
Excellent attention to detail and organization
Excellent written and verbal communication
Highest level of ethics and integrity
Ability to lead and motivate the right behaviors
Ability to multi-task and work in a fast-paced environment
Proficient in aseptic technique
Excellent documentation accuracy
Proficiency in Microsoft Office
Ability to follow SOPs and regulatory guidelines with precision
Physical Requirements:
Ability to work seated or standing for 8 – 10 hours Ability to lift, push, pull or otherwise transport objects or weighing up to 25lbs Qualifications/Requirements High school diploma or equivalent required At least 1 year of hands-on experience with aseptic technique required Experience working in an FDA-regulated environment preferred An associate's or bachelor's degree in a related field may be substituted for the required one (1) year of experience Clearance of favorable background investigation required
