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3 Key Consulting

MCS Manufacturing Associate, Biopharma (JP9784)

newbury park, CA

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Job description

MCS Manufacturing Associate, BiopharmaThe 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 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 scheduleBasic Qualifications:Bachelor's degree ORAssociate's degree and 4 years of Manufacturing /Operations experience ORHigh school diploma / GED and 6 years of Manufacturing /Operations experienceAble to work in teams to complete operational tasksAble to take direction well, follow documents and policies at all timesAble 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.Top Must Have Skills:Mechanical and technical abilityMust be able to work all shiftsMust be able to understand GMP and complianceMust take initiativeDay 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 experienceRed Flags:Not local in distance to AmgenNo degreeIf they are looking for research position, this is not it.They need mechanical experience or show aptitudeUnable 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.

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newbury park, CA, 91320, US

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