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Associate-Filling & Visual Inspection

Job

Astrix Technology Group

Fremont, CA (In Person)

Full-Time

Posted 4 weeks ago (Updated 2 weeks ago) • Actively hiring

Expires 6/3/2026

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Job Description

Pay Rate Low:
29 |
Pay Rate High:
31 Position Overview We are partnering with a leading pharmaceutical/biotech manufacturing organization to place a skilled Aseptic Manufacturing Operator on their production team. This is an outstanding opportunity for a detail-oriented professional with foundational GMP experience to contribute to a highly regulated, cleanroom environment. The ideal candidate demonstrates strong aseptic technique, a commitment to documentation accuracy, and a safety-first mindset.
Shift:
Sunday-Thursday | 10:00 PM - 6:30 AM (3rd Shift)
Pay:
Competitive + 15%
Shift Differential Type:
6-Month Contract |
Start:
April 27, 2026 - Est.
End:
October 27, 2026
Hours:
40 hrs/week | 8 hrs/day | 5 days/week What You'll Do Independently and accurately prepare all assigned records, calculations, and documentation in compliance with applicable SOPs. Properly handle and dispose of hazardous waste in accordance with established safety procedures and regulatory requirements. Practice aseptic techniques independently, including performing media fills (process simulation testing) with passing results per applicable SOPs. Perform clean room gowning and consecutively pass clean room garment validation. Independently prepare disinfectants and sanitizing solutions; clean and sanitize production equipment, rooms, and areas. Assist in performing environmental monitoring activities, including placing settling plates and conducting air sampling. Set up, operate, maintain, and troubleshoot steam sterilizers, capping machines, stoppering machines, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, L-bar sealers/bundlers, vision systems, inkjets, and vacuum check equipment as needed. Independently perform sterile filtration and aseptically gather and transfer samples for QC testing. Perform filter integrity testing and prepare accurate supporting documentation. Assist staff in developing, improving, or refining procedures and methods. Assist in training other employees within assigned areas of responsibility. What We're Looking For High school diploma or GED required; additional education or equivalent experience a plus. Minimum 2 years of experience in a manufacturing or regulated production environment; basic operator functions with exposure to GMP preferred. Demonstrated knowledge of federal, state, and international regulations including cGMP, USDA, DOT, EPA, and OSHA requirements. Familiarity with Standard Operating Procedures (SOPs), Material Safety Data Sheets (MSDSs), and hazardous materials handling. Understanding of aseptic processing procedures, laminar flow systems, and environmental monitoring principles. Knowledge of traffic patterns and BPE (Bioprocess Equipment) methods. Understanding of basic GMP and documentation practices. Successful completion of National Career Readiness Work Keys assessment preferred. Ability to work collaboratively within a team environment and demonstrate leadership principles. Must be able to lift up to 50 lbs. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! #INDBH #LI-DNI

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