Halo Pharmaceuticals

  • Lead Inspector, Quality Assurance

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

    The Lead Inspector, Quality Assurance, is responsible for performing duties related to but not limited to in-coming materials (i.e., sampling , review specification and release materials in SAP and any other related electronic database), line Inspections in Solid Dosage Forms production area, Santyl and packaging lines, reviewiewing batch records when required, performing all quality assurance activities in accordance with cGMP and standard operating procedures.

    Responsibilities

    • Perform all the function of a Sr. QA Inspector and QA Inspector when needed.
    • Assist the QA Manager with writing and investigating deviations.
    • Schedule the work load for the Inspection Group in the Supervisor absence.
    • Review SOPs.
    • Assist Sr. Inspector in the following functions as needed
      • Performs all the functions of an inspector, in addition reviews that all tasks performed by the QA Inspectors are performed accordingly.
      • Assist with decision making during an inspection and notify management.
      • Performs inspections for customer complaints.
      • Performs inspection of retain samples and complaint samples.
      • Performs DEA inventory.
    • Assist Inspector group in the following functions as needed:
      • Perform review of C of A or C of C for in-coming materials, verify the shipments meet Halo requirements, and notify Management of any discrepancies.
      • Perform all sampling of raw materials, packaging components and printed material following Halo SOP, ANSI, CFR and EHS guidelines.
      • Perform review of QC Specification; ensure all test result met specifications requirements and release of incoming materials, packaging components and printed materials in the electronic data base; Assign retest or expiry dates as per SOP.
      • Apply stickers to identify the materials status.
      • Perform QA inspection as per batch record in SDF, packaging lines adhering to all GMP and EHS guidelines.
    • Be able to work in a sterile environment.
    • Review packaging and manufacturing batch records, perform calculations and yields.
    • Perform AQL inspection and correctly identify a defect.
    • Review and release bathes in SAP for shipment.
    • Assist with other QA related tasks as delegated by QA Management.
    • Complete TrackWise assignments.
    • Other duties as assigned.

    Qualifications

    • Fully conversant with word processing, spreadsheet and database computer programs.
    • Communicates and multi-tasks effectively.
    • Accuracy – Ability to perform work accurately and thoroughly.
    • Time Management – Ability to utilize the available time to organize and complete work within given deadlines.
    • Accountability – Ability to accept responsibility and account for his/her actions.
    • Detail Oriented – Ability to pay attention to the minute details of a project or task.
    • Persistence – Ability to complete tasks or continue in a course of action in spite of opposition or discouragement.
    • Must wear personal protective equipment at times
    • Must be able to move about the facility
    • May be sedentary for extended periods of time

     

    EDUCATION

    • Post-Secondary education desirable.

     

    EXPERIENCE

    • 2-3 years working experience in QA, warehouse or material handling in a GMP environment, preferred but not required.

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