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Biotech Quality Assurance Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Sap, Client
Projektbeschreibung
Top Skills You Should Possess:
- Ability to successfully interpret and apply good manufacturing practices (cGMPs) in a production environment
- Minimum one-year experience in a Quality Assurance role required in a cGMP production environment.
What you'll Be Doing:
- Utilizing motorized walkie-stacker to move materials in order to conduct sampling of raw materials and bulk products.
- Conducting standard analysis and testing of packaging materials to ensure compliance with approved specifications.
- Rendering decisions as to conformance to current good manufacturing practices (cGMPs), standard operating procedures (SOPs), and plant quality standards.
- Collecting and maintain accurate documentation in appropriate computer system.
- Performing routine and non-routine (Stability) sampling of raw materials, intermediates and finished products.
- Review non-conformance of production operations and equipment/materials with supervisor in charge of area to assist with investigation and correction of problem.
- Perform resamples and overchecks to assist in problem investigation.
- Operate automated walkie-stacker with skids of raw materials or bulk to raw material sampling room in order to perform sampling and quality assurance evaluation of raw materials and bulks: summarize documents and report results.
- Perform required testing of packaging components, work in process (WIP), finished goods, and sample raw materials to ensure that approved specifications are met.
- Perform Berthold testing for radioactivity of raw materials sourced from Japan.
What You Need to Bring to the Table:
- At least two (2) years of post high school education is required. Associate's degree is preferred.
- At least one-year (1) experience in a Quality Assurance role required. (QA role is defined as demonstrated ability to successfully interpret and apply cGMPs in a production environment.)
- Previous experience working in good manufacturing practices (GMP) and/or government regulated industry required.
- Knowledge of Standard Operating Procedures (SOPs), quality assurance terminology, statistical techniques, production processes, Acceptable Quality Level (AQL), and monographs/specification sheets is preferred.
- Personal Computer (PC) skills required; Microsoft Office, Lotus Notes, SAP, MES experience preferred.
IF THIS SOUNDS LIKE YOU, APPLY NOW!/APPLY NOW!
RECRUITER: JAMES DANGLER
Yoh, a DayJ2W: PROF
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Ref:
SFSF: ENG
Projektdetails
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Einsatzort:
Myerstown, 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, SAP Entwicklung