WuXi AppTec

  • Supervisor Technical Operations

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3567
  • Overview

    Responsible for building and supervising a team of manufacturing specialists tasked with authoring change controls, investigations of root cause, deviations and CAPAs, and performing first level review of batch records / logbooks. Focus on driving efficient processes and first time quality.

    Responsibilities

    Team formation o Build a team of technical operations specialists. Team will focus on coordination and receipt of information from multiple departments and ensure on-time lot release. o Staffing and training of employees within area of responsibility. Effective resource management using cross training and flexible creative approach o Develop and manage metric systems to monitor performance within area of responsibility  Documentation Management o Responsible for driving efficient batch record, deviation, CAPA and change control closure via visual boards, daily operations meetings or other avenues. o Supervise technical operations specialists focused on tracking and facilitating closure of batch records, change controls and other documentation required for batch release.  Investigations o As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. o Prepares and analyzes manufacturing and historical data, and uses methodical root-cause analysis tools to determine root causes and effectively documents the root cause. o Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools. o The individual in the position provides technical expertise to the site on thorough and complete deviation investigations.

    Qualifications

    Experience / Education:

    • HS Diploma or equivalent required and
    • 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
    • BS/BA in Science related field preferred; or combination of relevant Experience & Education

    Knowledge / Skills / Abilities:

    • Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
    • Ability to work under limited supervision and to handle problems of a more difficult nature.
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
    • Holiday and shift work often required based on manufacturing schedule as determined by Area Management.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions.
    • Must be able to work in Lab setting with Biohazards /various Chemicals
    • Must be able to wear appropriate PPE
    • Must be able to work in environment with variable noise levels
    • Ability to stand /Sit/walk for long periods of time
    • Ability to Lift 20 lbs routinely
    • Ability to crouch, bend, twist, and reach
    • Ability to push/pull 20 lbs routinely/ often / occasionally
    • Clarity of Vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions
    • Ability to climb Ladders / Stairs / Scaffolding
    • Ability to work in variable temperatures high to freezing
    •  Inside/outside working conditions

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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