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Fujifilm Biotechnologies - California Biotech Workforce Accelerator Program
Administered through Integrity Consulting
Click Here For Program Information
Junior Manufacturing Associate
JOB DETAILS:
- $25hr depending on experience W2
- Part Time up to 20 hours per week
- Onsite in Thousand Oaks, CA
SUMMARY OF POSITION:
The Junior Associate, Manufacturing (Part-Time) supports day-to-day manufacturing operations in a GMP regulated environment with an emphasis on aseptic practices, good documentation practices (GDP), and compliance with standard operating procedures (SOPs
).
This position is an entry level position for biotechnology students and exists to ensure reliable, compliant execution of routine tasks that enable safe, timely, and efficient production. The candidate must be entering junior or senior year of a Bachelor’s program in Biotechnology, Biology, or a related life science and is eager to learn GMP manufacturing practices. This role supports the delivery of high-quality therapeutics and contributes to the success of clinical trials and commercial production.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Performs media batching in Grade A, to include environmental monitoring operations.
Support visual inspection of final drug product, labeling and control rate freezing of dug product
Executes production batch records according to SOPs and work instructions.
Perform disinfection and staging of various materials according to company procedures.
Execute cleaning and sanitization of the manufacturing facility and equipment in a manner consistent with the safety policies, quality systems, and GMP requirements.
Document and review records, daily logs, and documentation following Good Documentation Practices.
Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
Support inventory management activities.
REQUIRED QUALIFICATIONS
Currently enrolled in a Bachelor’s degree program in Biotechnology, Biology, Biochemistry, Microbiology, Biomedical Engineering, or a closely related field; entering or currently enrolled in junior or senior year
Academic or hands-on lab experience with aseptic technique and sterile handling.
Familiarity with GMP concepts and GDP from coursework or prior internship/co-op.
Experience in a controlled laboratory or cleanroom environment, a plus.
Must be available to work various shifts as needed, up to 20 hours per week including weekends and holidays as needed.
High school diploma or equivalent required.
Legible handwriting
WORK ENVIRONMENT:
Work is generally performed in a Good Manufacturing Practice (GMP) facility. A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:
Makeup, painted nails
Hair products (spray, gel, wax)
Perfume and cologne
Jewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear piercings, etc.)
Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment
Personal Protective Equipment is required to perform certain tasks (i.e., latex/nitrile gloves, respirators and or masks, goggles, plant dedicated scrubs/shoes, full body gown that covers all exposed skin)
Subject to extended periods of standing, to include crouching / kneeling, while being donned in applicable PPE
Required to handle biohazardous and hazardous material via direction of Standard Operating Procedures
PHYSICAL REQUIREMENTS:
Medium work that often includes moving, lifting, pushing and or pulling objects up to 50 pounds
Medium work that often includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels
Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
Position requires a combination of standing in the manufacturing environment and walking around the facility
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