MCS Manufacturing Associate, Biopharma; JP

MCS Manufacturing Associate, Biopharma

The Associate of Manufacturing will work in a dynamic production environment at the client's Thousand Oaks Site supporting development, clinical, and launch 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 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 reports
• Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (equipment logs, batch records)
• Performing activities that include periods of rigorous, repetitive work
• Working around high-pressure systems and occasionally work around heavy equipment
• Available to work various shifts (day, swing, 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
• Able to take direction well, follow documents and policies at all times
• Able to take initiative
• Creates 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.

Top Must Have

Skills:

• Mechanical and technical ability
• Must be able to work all shifts
• Must be able to understand GMP and compliance
• Must take initiative

Day to Day Responsibilities:

Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves to support the manufacture of drug substance using SOP's.

Employee Value Proposition:

Extension is highly likely - unique knowledge and experience

Red Flags:

• Not local in distance to Amgen
• No degree
• If they are looking for research position, this is not it.
• They need mechanical experience or show aptitude
• Unable to work all shifts and be flexible (evenings, weekends, etc)

Interview process:

Phone and Webex.

We invite qualified candidates to send your resume to  If you decide that you're not interested in pursuing this position, please feel free to look at the other positions on our website  You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.