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Quality Assurance Associate

Quality Assurance Associate

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Quality Assurance Associate

  • Location:

    Whitestown

  • Sector:

    Quality Assurance & Validation - Pharma

  • Contact:

    Jonathan Buggs

  • Salary:

    US$20.00 - US$23.00 per hour

  • Job type:

    Interim/Contract

  • Contact email:

    Jonathan.Buggs@msipharma.com

  • Job ref:

    JBQAASFEB24_1713533303

  • Published:

    about 1 month ago

  • Duration:

    6 month

  • Startdate:

    ASAP

General Summary: The Plasma Logistics Coordinator plays a critical role in ensuring the efficient and compliant handling of plasma units within the Plasma Logistics Center (PLC). This position is primarily responsible for the identification, removal, and proper disposal of all plasma units deemed unacceptable. Additionally, the associate oversees day-to-day activities at the PLC, including shipment release and closing, temperature monitoring, cGMP training, and management of special product requests.

Responsibilities:

  1. Handle unsuitable plasma units, applying labels/overlays as needed and generating reports on their disposition.
  2. Control shipments designated for destruction, ensuring adherence to cGMP requirements and maintaining proof of destruction.
  3. Review and release outgoing plasma shipments, and close inbound shipments upon full receipt in LOGIC.
  4. Utilize LOGIC functions for all quality-related actions.
  5. Perform periodic temperature-related activities as outlined in SOPs, including daily checks and calibrations.
  6. Conduct safety checks, unit relabeling, and pest management service reviews as needed.
  7. Maintain the Learning Management System to ensure data integrity and compliance with company and regulatory standards.
  8. Coordinate and monitor training delivery to meet center and regulatory requirements.
  9. Handle special requests such as lab requests, third-party shipments, and non-injectable shipments.
  10. Communicate clearly with internal stakeholders and outside vendors both verbally and in writing.
  11. Adhere to all SOPs, company policies, and procedures.
  12. Identify and report issues that may compromise product safety or quality to PLC Management, investigating and documenting incidents as necessary.
  13. Perform other duties as assigned to support business needs.
  14. Operate a forklift (Forklift Truck) as required.

Working Conditions (Physical & Mental Requirements):

  • Ability to make impactful decisions and communicate technical information effectively.
  • May be required to work overtime and extended hours.
  • Frequent standing, bending, twisting, and walking.
  • Ability to lift or carry up to 50 lbs.
  • Fast-paced environment with frequent interruptions.
  • Frequently required to wear personal protective equipment.
  • Occasionally exposed to bloodborne pathogens and extreme temperatures (-25°C or colder for freezers, 5°C for cold room) during material retrieval.

Note: This is a 100% on-site position with the possibility of becoming permanent based on performance and business needs.