Aseptic Process Technician - Cleanroom & FDA Compliance

Jobtailor; San Diego (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Jobtailor in San Diego, CA is seeking an aseptic manufacturing associate to support sterile tissue processing under SOP and GDP guidelines. This role requires adherence to regulatory standards and precise documentation.

Responsibilities include completing training, maintaining aseptic competency, reporting deviations, performing cleanroom tasks, and ensuring on-time attendance with overtime as needed.

Qualifications

• 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.
• A higher level of education may be considered in lieu of 1-3 years of required experience.

Responsibilities

• Complete assigned training on 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 SOPs.
• Apply 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 SOPs.
• Accurately 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.

Skills

Aseptic Technique

Good Judgment

Attention to Detail

Time Management

Education

High School Diploma or Equivalent

Associate's or Bachelor's Degree in related field

Job description

Jobtailor in San Diego, CA is seeking an aseptic manufacturing associate to support sterile tissue processing under SOP and GDP guidelines. This role requires adherence to regulatory standards and precise documentation.

Responsibilities include completing training, maintaining aseptic competency, reporting deviations, performing cleanroom tasks, and ensuring on-time attendance with overtime as needed.