QC Cell and Immuno Biology Supervisor-US-RI

sciresec eric at scientificresources.com
Wed Jan 10 17:40:27 EST 2001


HIRING PROFILE

      TITLE:


     QC Cell and Immuno Biology Supervisor

      REPORTS TO:


     QC Manager

      EDUCATIONAL REQUIREMENTS:


     BS

      EXPERIENCE


     ·        8 years with 5 years QC experience in GMP or GLP environment

      ·        previous supervisory experience preferred

      ·        experience with bioassays, cell culture and ELISAs

      RESPONSIBILITIES:

      ·        Maintain regulatory compliance through established lab
programs for maintenance, training, SOPs, validation and cleaning in area of
responsibility

      ·        Meet established schedules to support production and facility
requirements

      FUNCTIONAL:  (Near 12 - 18 Months vs./ long term)

      ·        establish ELISAs, receptor binding assay and bioassay methods
to support newly introduced manufacturing process through technology
transfer

      ·        train and supervise 2 - 5 analysts in QC Cell and Immuno
Biology laboratory

      ·        review laboratory testing documentation

      ·        troubleshoot lab methods and instruments

      ·        create and maintain up-to-date laboratory SOPs and validation
documents for lab equipment and test procedures

      ·        perform trend analyses as required



      INTERACTION:

      Internal: Managers / Supervisors / Professionals / Non-exempts

      External: Vendors / Business partner counterparts



      MANAGERIAL:

      Supervise 2 - 5 employees



      STAFF DEVELOPMENT

      Responsible for development of direct reports through training and
coaching exercises











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