Job Summary
The Associate of Manufacturing will work in a dynamic production environment in a Thousand Oaks Drug Substance plant supporting development, clinical, and commercial activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).
Responsibilities include:
• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Performing and monitoring critical processes with the ability to perform basic troubleshooting
• Performing in-process sampling of equipment and operating analytical equipment
• Performing washroom activities: clean small-scale and large-scale equipment used in production activities
• Maintaining an organized and clean workspace
• Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet, and gloves when performing all work
• Initiating quality deviation records
• Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (example: batch records)
• Performing activities that include periods of rigorous, repetitive work
• Working around high-pressure systems and occasionally working around heavy equipment
• Available to work various shifts (Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
Basic Qualifications:
· Bachelor’s degree OR Associate’s degree and 4 years of Manufacturing /Operations experience OR High school diploma / GED and 6 years of Manufacturing /Operations experience
· Able to work in teams to complete operational tasks
· Ability to take direction well, follow documents and policies at all times
· Ability to take initiative
· Create a positive work environment through interactions with team members
· Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations
· Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.
Preferred Qualifications:
• Bachelor’s Degree in Biology and/or Life Sciences
• Mechanically inclined
Employee Value Proposition:
• Great way to get some GMP and production experience, especially for bio-technology. Huge part in getting these effective drugs out to the clients.