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Randstad Life Sciences US

MCS Manufacturing Associates - multiple needed!

Randstad Life Sciences US, Thousand Oaks, California, us, 91358


Immediate opportunity for four (20) MCS Manufacturing Associates. The Associate of Manufacturing will work in a dynamic production environment at the Thousand Oaks Drug Substance plant at one of the world's leading biotechnnology companies located in Thousand Oaks, CA. As a Manufacturing Associate, you will be 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).

Shifts:

Available to work various shifts (Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production scheduleDays, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs, as dictated by the production schedule4 x 10 Sun – Wed or Wed – Sat, Days or Swings4 x 12, 3 x 12 Sun-Tues/Wed orWed/Thurs- Sat, Days or GravesMust be flexible to work multiple shifts; cannot guarantee a shift before hire.

Position type: 6 months (through April 2025); extension likely up to 18 mos.

Position Overview:

The Associate of Manufacturing will work in a dynamic production environment at the Company 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).

Essential Duties and Responsibilities:Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipmentPreparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)Following GMP documents (SOPs, MPs) with strict adherence to safety and compliancePerforming and monitoring critical processes with the ability to perform basic troubleshootingPerforming in-process sampling of equipment and operating analytical equipmentPerforming washroom activities: clean small and large scale equipment used in production activitiesMaintaining an organized and clean workspaceWorking in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all workInitiating quality reportsDrafting and revising documents (SOPs, MPs)Identifying, recommending, and implementing improvements related to routine functionsAssisting in the review of documentation for assigned functions (equipment logs, batch records)Performing activities that include periods of rigorous, repetitive workWorking around high-pressure systems and occasionally work around heavy equipmentAvailable to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production scheduleAble to work in teams to complete operational tasks Able to take direction well, follow documents and policies at all times Able to take initiativeCreates positive work environment through interactions with team membersAble to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durationsAble 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.

Qualifications:Bachelor's degree (BS) OR Associate's degree (AS) and 4 years of experience OR High school diploma / GED and 6 years of experience.Mechanical ability/expertiseBasic statistical mathematical skillsAbility to interpret and apply GMP knowledgeUnderstanding of analytical methods for manufacturing areaDemonstrated technical writing capabilityAble to demonstrate project management skills and presentation skillsAbility to understand, apply and evaluate basic chemistry, biology and physical principlesBasic troubleshooting skills on production equipmentExperience with Delta V is a plusExperience with lab equipment/testing