Halo Pharmaceutical

  • Production Supervisor

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Production Supervisor is a cross functional position encompassing, but not limited to the Supervision of the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Injection Molding,  and Chemical manufacturing process.

     

     

    This position is for the 2nd Shift which runs from 3pm - 11:30pm. 

    Responsibilities

    1. Reports to manufacturing upper management. 
    2. Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
    3. Comprehends and adheres to all cGMP’s and other Regulatory requirements.
    4. Respond to questions from outside regulatory agencies including the FDA, DEA.
    5. Comprehends and adheres to all related SOP’s as well as Batch Records and Protocols.
    6. Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
    7. Completes all required Training activities.
    8. Clearly and accurately completes all required GMP documentation.
    9. Perform Room and Equipment inspections and completes all pertinent documentation.
    10. Manual Dexterity is required.
    11. Other duties as assigned

    Qualifications

     

    • Has authority for personnel actions and oversees most day to day operations of various unit operations within the Dosage Forms area.
    • Perform work in compliance with established cGMP and SOPs.
    • Respond to questions from outside regulatory agencies including the FDA, DEA.
    • May be resposible for the receipt, storage and issuance of all Contriolled Substance material activities within the Dosage Forms area.
    • Generaqtes Demand Work Orders as needed.
    • Establishes or revises SOP’s as required.
    • Initiates Planned and Unplanned Deviations as required.
    • Schedules and assigns manufacturing personnel to their daily job assignments.
    • Evaluates for disposition employee Paid Time Off requests.
    • Secures quotes and arranges for vendor service calls as needed.
    • Orders supplies for the department as needed.
    • Generates employee Performance Appraisals and Disciplinary documentation.  
    • Computes amounts of materials and supplies required for operations, based on production schedules, and requisitions or directs the requisition of materials from storage areas.
    • Plans flow of materials through the department and plans work according to manufacturing schedule.
    • Interfaces with others in the organization as well as clients to ensure customer deadlines are met.
    • Inspects and approves manufacturing rooms and equipment for cleanliness and completes the required documentation.
    • Manages and schedules employee overtime as needed.
    • Directs workers in adjusting machines and equipment to meet required specifications.
    • Performs batch record reviews prior to disposition.
    • Develops, recommends, and implements measures to improve production methods, equipment performance, and quality of product.
    • Analyzes and resolves work problems, or assists workers in solving work problems.
    • Ability to read, analyze, and interpret SOPs, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, etc...  Ability to effectively present information and respond to questions from groups of managers, clients and outside regulatory agencies.
    • Computer literacy and solid communication skills (in English) are a must.
    • Must demonstrate Basic Math skills.
    • Ability to move/push up to 50lbs.
    • Must be able to move about the facility.
    • Must be able to remain sedentary for extended periods of time.

     

    EDUCATION:     

    • Bachelor's degree from four-year College or university; or three to five years related experience and/or training; or equivalent combination of education and experience.

    EXPERIENCE:

    • Three to five years related experience and/or training; or equivalent combination of education and experience.
    • Experienced interaction with regulatory agencies including the FDA, DEA.
    • Solid understanding of cGMP practices and concepts.
    • Mechanically inclined candidates are preferred.

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