What You’ll Do
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Provides on-the-shop-floor support for WH area in collaboration with WH personnel, e.g. walkthroughs, shipment related inspections and approvals and other tasks as assigned.
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Review and approval of relevant WH and SC quality records, to include deviations, CAPAs, Change Controls (CMR), logbooks, and other records as assigned.
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Author, Review and Approve documents in the relevant Electronic Document Management System (EDMS)
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Review and Approve alarm notifications in WH area
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Review and Approve Work Orders for WH/SC area as needed
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Appropriately disposition material status in SAP for WH/SC areas
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Performs other duties, as assigned
Minimum Requirements:
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Bachelor’s in Life Sciences or Engineering or equivalent with 2+ years of applicable experience OR
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Master’s in Life Sciences or Engineering or equivalent with 0 years of applicable experience
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1-3 years’ experience in a GMP environment
Preferred Requirements:
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5+ years of experience in GMP environment.
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Experience working within a QA role in the pharmaceutical industry
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Experience with TrackWise
Working Conditions & Physical Requirements:
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. minutes)
No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
Ability to sit for prolonged periods of time. minutes)
No X Yes Daily up to 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No x Yes
Ability to operate machinery and/or power tools. x No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No x Yes
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
