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    Duties

    Summary

    The Research Production Controller (RPC) is a full performance level position located in the Clinical Materials Management Section (CMMS) and Clinical Manufacturing (CMS) Section of the PCC. The primary purpose of the RPC is to manufacture, package and label drugs/devices {hereinafter referred to as clinical supplies). The primary purpose of the RPC is to manufacture, package and label drugs/devices.

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    Responsibilities

    Clinical Supply Production Planning

    Prepares a "production plan" for each multicenter project assigned. The production plan requires selecting a distribution scheme; designing the patient kit design; establishing specifications; selecting types of packaging materials; determining labelling design and specifications and needs (e.g., design, print and ink, material, adhesive, bar code, etc.), precision production equipment requirements and needs (e.g., tablet presses and capsule fillers, automated bottle, blister card, label, and form fill equipment, etc.) which consist of many precise mechanical production modules; estimating clinical supplies; estimating personnel and annual man hours required for automated and non­ automated activities; and proposing an annual production schedule for each assigned MCT. Ensures that all specifications proposed comply with current Good Manufacturing Practices (cGMP).

    Clinical Supply Production and Distribution

    Releases production orders, monitors the progress and the completion of production runs, resolve in-process problems (fiscal, materials, equipment, and manpower) as they occur and reschedules production runs as necessary.

    Clinical Supply Specialization

    Must have expertise and be able to adequately function in at least three of the following technical specialty areas as determined by the supervisor:

    1. clinical supply acquisition, bar code assignment and use;
    2. clinical supply receipt, storage, and bar coding (warehouse);
    3. precision manufacturing (tablets, capsule, and overcoating /active and placebo dosage formulations);
    4. automated precision clinical bottle packaging and bar coding;
    5. automated precision clinical blister card and form fill packaging;
    6. precision robotic clinical label production, bar coding and application;
    7. quality control sampling and precision drug assay;
    8. clinical supply returns accountability via bar code and disposition;
    9. clinical supply precision bar code processing;
    10. clinical supply distribution via bar code and shipping;
    11. training - standard operating procedures/approved methods and procedures and study procedures;
    12. precision equipment monitoring, maintaining and repair schedule

    Work Schedule: Monday-Friday, 8:00 am to 4:30 pm
    Compressed/Flexible: Not available
    Telework: Not available
    Virtual: This is not a virtual position.
    Position Description/PD#: Production Controller/PDPD02907-A
    Relocation/Recruitment Incentives: Not authorized
    Financial Disclosure Report: Not required

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    None

  • Job family (Series)

    1152 Production Control

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/556797500. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.