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Process Development Associate II Job
Eingestellt von Yoh
Gesuchte Skills: Support, Oracle, Sql, Client
Projektbeschreibung
THE BIG PICTURE:
- Support shipping and transport logistics, coordinate product delivery and pick up
- Coordinate logistics for distributing innovator product samples to PD and QC labs per the established sample plans
- Enter data into LIMS and perform data verification to the source documents if applicable
WHAT YOU'LL BE DOING:
- Plan and initiate purchase orders to ensure innovator product supply meets predefined inventory targets for the similarity and Non clinical demands
- Coordinate daily activities for developing and managing innovator product demand and forecasts
- Manage inventory of all the reference products, elevates any impact to the relevant Analytical lead
- Coordinate sample distribution per the schedule established in Biosimilars Reference product distribution calendar
- Organize and communicate on a regular basis the total demand and supply requirements to senior management
- Proactively communicate inventory and logistical challenges - provide implementable solutions
- Support quarterly budget exercise by compiling the received orders and revising inventory demand
- Creation and maintenance of Biosimilars Reference Product -static data in Amgen's SampleManager LIMS
- Laboratory Information Management System following Templating procedures
- Coordinate Sample login and custody in LIMS following appropriate GMP procedures
- Perform data verification of the SAS files that are part of regulatory filings
- Data management collation and facilitation between Amgen functional areas
- Execute business object report queries to extract and compile the verified data from LIMS
- Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget
- Accountable for achieving data compilation and accuracy targets per established project timelines
- Other objective tasks may be assigned
WHAT YOU NEED TO BRING TO THE TABLE:
- Master's degree with 0 - 2 (two) years or Bachelor's degree with two to four (2 - 4) years or Associate's degree with four (4) years of directly related experience
- Must be skilled in the use of Microsoft Excel and other MS Office tools
- Experience with template development on the SampleManager LIMS product of ThermoFisher Scientific, Inc.
- Oracle or SQL-based database query tools
- Good written and oral communication skills
- Strong project management, communication and organization skills
- Strong analytical problem solving skills
- Possess an understanding and appreciation of the Amgen Values and Leadership Attributes
- Experience with SAS programming
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Previous work in a GDP
- environment is highly desired
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Salima Hakim
Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.
J2W: SCIENTIFIC; J2W: CLINICAL
MONJOB J2WSWSCI
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Thousand Oaks, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges