Manager, Sample Quality
Job Description The Sample Quality Manager is responsible for management of incoming sampling including receipt, sampling, physical testing and labeling of incoming materials as well as outgoing bulk released materials.
Responsible for systems for management of the above activities Additional areas of responsibility in sample control include receipt, logging and management of all samples for QC testing at the RTP site.
Additionally responsible for generation of QC Certificates of analysis and maintenance of laboratory data packages.
Responsible for systems for management of the above activities Responsible for development of systems to ensure compliance with regulatory requirements.
This will include vendor approval activities, specification revisions and approvals, retain sample management, pre approval samples, tailgate samples, status labeling, barcoding, and NIR technologies Will be responsible for key communications with other Biogen Idec sites including international.
Qualifications 7-10 years of QC, Sample Managment, Vendor Management, Incoming area 2-5 years supervisory experience Experience with GMPs (European and FDA preferred) as they relate to sample control/management Solid communication skills Knowledge of NIR technologies, Materials Management Systems, LIMS, Nautilus is preferable Must possess solid leadership skills Quality system implementation a plus Must be able to operate at the global level.
Education Requires a BS degree in Chemistry, Biology, Biotech or related area.
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