Biotech Quality Control Inspector - 2nd Shift

Sanisure; Camarillo (CA); On-site; USD 52,000 - 68,000; Full time

Job summary

SaniSure is a high-growth manufacturer of single-use products for biologics, with operations in the U.S. and Europe. The Quality Control Inspector will inspect materials, parts, and products at multiple production stages to ensure adherence to specifications and regulatory requirements.

The 2nd shift is 3:00pm - 11:30pm, involving NCR initiation, data recording, and cross-functional collaboration. Strong documentation practices here are essential.

Qualifications

• High school diploma and 3+ years in quality control inspections.
• Experience with GMP operations following SOPs and good documentation practices.
• Experience in pharmaceutical/medical device quality manufacturing.
• Knowledge of ISO 9001/13485 and 21 CFR Parts 210/211 or 820.
• Ability to work in ISO environments with PPE and proper safety protocols.

Responsibilities

• Perform quality inspections and ensure compliance with applicable regulatory authorities.
• Initiate nonconformance reports (NCR).
• Record observations and recommend process improvements.
• Inspect incoming, first article, in-process, and final product stages.
• Support cross-functional investigations related to non-conformance findings.
• Ensure all inspections and procedures are properly completed and documented.
• Perform pre- and post-inspection of product for gamma irradiation processes.

Skills

Quality inspections

GMP knowledge

Documentation practices

SOP adherence

Communication skills

Teamwork

Mathematical skills

Regulatory awareness

Education

High School Diploma or equivalent

Tools

Syteline ERP

Job description

SaniSure is a high-growth manufacturer of single-use products for biologics, with operations in the U.S. and Europe. The Quality Control Inspector will inspect materials, parts, and products at multiple production stages to ensure adherence to specifications and regulatory requirements.

The 2nd shift is 3:00pm - 11:30pm, involving NCR initiation, data recording, and cross-functional collaboration. Strong documentation practices here are essential.