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Pilot Plant Compliance Specialist Whippany, New Jersey

Company: Cambrex
Location: Whippany
Posted on: August 7, 2022

Job Description:

POSITION SUMMARY

  • The Pilot Plant Compliance Specialist is a multi-faceted position supporting all aspects of the Pilot Plant including Batch Record and GMP compliance documentation, scheduling, equipment/supply requisition and Key Performance Indicator (KPI) tracking
    ESSENTIAL FUNCTIONS
    • Supports the Pilot Plant with the following:
    • Assisting or authoring in preparation of cGMP documents such as Investigations, SOPs and change controls
    • Monitors Calibration and Preventive Maintenance on GMP equipment to ensure compliance - Performs document reviews for Manufacturing/Packaging Batch Records.
    • Plan for the execution of batches in PD and coordinate with Project Managers Key Job Responsibilities - Maintain correct inventories by location in SAP
    • Works with department supervision when batch record data entry corrections are required
    • Review for completeness, issuance of raw materials and yield confirmations for Manufacturing Orders. - Secures supplier quotes and creates purchase requisitions as needed. - Collects data to compile Key Performance Indicators (KPIs)
    • Monitors SOP and Logbook effective dates and ensures department supervisors stay current with SOP reviews and Logbooks
    • Orders supplies as needed - oversees/tracks department Investigation and CAPA due dates
      POSITION QUALIFICATIONS
      • Ability to use computer systems including SAP, Trackwise, and the site's documentation management system
      • May be required to wear personal protective equipment - Good communication, interpersonal and organizational skills with the ability to manage multiple tasks with attention to detail
      • Proficient with MS Office, SAP and TrackWise
      • Ability to demonstrate effective problem resolution
      • May be required to lift up the 10 lbs
        EDUCATION:
        • BA/BS in a related field (science preferred)

          Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
          #LH-SS1 #CB

Keywords: Cambrex, New York , Pilot Plant Compliance Specialist Whippany, New Jersey, Professions , Whippany, New York

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