Transportation Quality Systems Specialist

On Application
27 Nov 2018
27 Dec 2018
Quality, QA / QC
Contract Type

Transportation Quality Systems Specialist

11 month contract with option to extend

This position works closely with Order Management, Transport Ops Team, Supply Chain and Distribution QA and other Internal Customers and external service providers. 

The Transportation Quality Systems & Documentation specialist is responsible for the oversight and management of the global transportation Quality Systems associated with 3PL replenishment shipments, CMO stock transfers and Non-Commercial shipments.

This position works closely with the Supply Chain Transportation teams to drive continuous improvement in quality systems and develop corrective actions to reduce deviations.

This position is responsible for documentation management including but not limited to Internal SOPs and Work instructions as well as supporting external partner document processes for domestic and international shipments.


Quality System Management:

  • Ensuring all quality systems are addressed and resolved in a timely manner to minimize impact on product supply.
  • Manage Deviations, CAPAs and Change controls for commercial and non-commercial shipments.
  • Lead and manage temperature deviations to closure and within established timelines. Specifically, conduct comprehensive investigations to identify root cause and implement corrective and preventative actions.
  • This position ensures Transportation processes are in line with GDP guidelines, regulatory and quality requirements.


  • Develop and revise documentation such as procedures, work instructions and job aids applicable to 3PL replenishment, CMO Transportation and Non-Commercial shipments.
  • Ensure all documentation, with both internal and external partners, are up to date and reflect the current process.
  • Revise internal procedures as needed to maintain a robust process for supplying drug products to Shire patients in a compliant manner.
  • Promote GDP compliance and Cold Chain excellence related to Cold Chain validation documentation and Validation testing. 
  • Support training development and conduct training for employees and external service providers.
  • Identify Gaps in current transportation processes and develop and implement appropriate updates as needed.


  • Support External Audits as it relates to Freight Forwarder storage and TSA screening facilities, CMOs, Distribution centers and Supply Chain Vendors.
  • Support Internal Audits on Transportation procedures and all quality systems within Trackwise.

Education & Experience Requirements


  • BA/BSc in related field with Minimum 3+ working in a cGMP environment.
  • Experience conducting investigations, working knowledge of logistics and experience with temperature sensitive product distribution.


  • Experience working in Pharmaceutical or highly regulated and compliance industry, cold chain temperature-controlled products. BS and APICS Certification preferred.

Key Skills and Competencies

  • Fluent in English in verbal and written communication.
  • Proficient in writing and compiling concise documentation.
  • Experience in Trackwise preferred.
  • Previous technical writing preferred. 
  • Strong organization skills and attention to details.
  • Exceptional oral skills and written communication skills
  • Ability to work with both independently and in a cross-functional environment including external service providers.
  • Excellent time management skills.
  • Knowledge of cGMP manufacturing and end-to-end supply chain, as well as detailed knowledge in global logistics 
  • Knowledge of MS office tools (Outlook, Word, PPT, excel, access, project)


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