Logistics Coord

Integrated Resources, Inc

Zebulon, NC

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JOB DETAILS

SKILLS

Budgeting, Clinical Trial, Communication Skills, Consulting, Continuous Deployment/Delivery, Continuous Improvement, Data Entry, Data Quality, Detail Oriented, Documentation, Establish Priorities, Follow Through, GMP (Good Manufacturing Practices), Housekeeping/Cleaning, Identify Issues, Interpersonal Skills, Logistics, Medical Products, Negotiation Skills, Operational Support, People Management, Printers, Printing, Problem Solving Skills, Productivity Management, Public/Media/Press/Analyst Relations, Purchase Orders, Quality Management, Quality Metrics, Reconciliation, Regulatory Compliance, Risk Analysis, Safety Compliance, Safety/Work Safety, Team Lead/Manager, Time Management

LOCATION

Zebulon, NC

POSTED

1 day ago

This work is being done at a client site in Zebulon, NC.
Full time on site
Monda-Friday 8-5pm

Description:
Produce clinical trial materials (CTM) for domestic and international clinical trials. Responsible for performing label printing/inspection and documentation preparation activities to meet the required GMP quality standards.

Key Responsibilities:
Note:
list activities that comprise the job including aspects of budget control, people management, technical activities, health & safety, GMP and individual specific activities.
Must assure clinical trial materials (CTMs) are produced in accordance with packaging orders to achieve useful results. CTMs
are produced in compliance with applicable regulations. Identifies problems and deviations, and makes recommendations on
solutions to ensure deadlines are met. Does not perform final verification/quality critical checks unless trained to perform a
specific check.
-Print and inspect clinical labels for use in clinical trials including bay set-up and line clearance.
-Prepare data entry for primary or secondary packaging documentation in accordance with GMPs and Standard

Operating Procedures
-Ensure high levels of attention to detail and data accuracy to documentation
-Use systems that are critical to the delivery of labels and packaging documentation (e.g. ClinPro, PTMS, COMET, or future applicable systems), recognize when it is necessary to seek support to resolve systems issues
-Ensure routine tasks (i.e. Print head checks) are performed in accordance with their required schedule
-Executes assigned tasks and activities with high quality and attention to own and other s safety
-Ensure that any non-standard activities that occur during label or documentation preparation are appropriately raised to team coordinator or supervisor (e.g. Deviations)
-Acts as first line resolution of quality, productivity , and safety issues.
-Verify equipment set up including quality critical settings.
-Complete and verify reconciliations of labels
-Anticipates/recognizes potential problems with equipment/materials and initiates action to address or prevent problems.
-Identifies and begins to interpret problems in processes and/or in results and communicates them to his/her supervisor
-Consults with supervisor when difficulties arise that cannot be readily resolved
-Work with trainees to complete training modules and assess training competency of specific activities.
-Participate in safety risk assessments.
-Identify and participate in delivery of continuous improvement opportunities in order to improve quality, productivity, and safety.
-Responsible for requesting labels for the on-time completion of jobs
-Participate in Quality Investigations as a technical expert in a manner subject to L2/L3/L4 scrutiny, when appropriate
-Participate in local and regulatory audits (compliance and safety).
-Write and obtain approval of observation reports
-Learning to present concise summaries of own activities in group settings
-Participate on inter-department project teams to meet company milestones and objectives
-Prepares brief oral or written summaries of results with interpretation for projects
-Assist in primary and secondary packaging floor operations as needed (with appropriate training)
Development of expertise in label printing and inspection and document creation

Specific Activities (as required):
Label Preparation
Documentation Preparation
Printing Labels (Open or Blinded)
Creation of Secondary Packaging Record (SPR) for Open Label supplies
Checking 2D Barcodes
ClinPro data entry for Open Label supplies
Receipt and dispensing of booklet labels
Creation of Expiry Packaging Record (PR)
Printer Cleaning / Maintenance Checks
Data entry into ClinPro for Expiry jobs
5S Audit Rota
Approval of SPR for Open Label supplies
Line Clearance
Approval of ClinPro Data Entry Open Label supplies
Verification of Line Clearance
Creation of SPR for Double Blind resupplies
Inspect Printed Labels (Open or Blinded)
ClinPro data entry for Double Blind resupplies
Manage label and printer ribbon stock; receive and re-order as appropriate
Approval of SPR for Double Blind resupplies
Approval of data entry for Double Blind resupplies
Approval of Expiry PR
Approval of ClinPro data entry for Expiry jobs
Creation of Expiry job package
Approval of Expiry job package
Download and Importing of random codes
Creation of code break container types
Approval of code break container types
Creation of Double Blind SPR (initiation to completion)
ClinPro Data Entry Double Blind (initiation to completion)
Generic Activities: Train other staff, as appropriate; Respond to Observation Reports; Participate in L1 audits; Serve as a
Fronter on L2 audits; Prepare SOP updates; Order/monitor blank label stock; Raise purchase orders (e.g. blank label stock);
Test and approve blank labels (as needed)

Competencies
Note: Include breadth & depth across disciplines or functions; behaviours and expertise in field required
-Sufficient education, experience and knowledge of the following:
-GMPs (current Good Manufacturing Practice) and other applicable regulatory requirements
-Understanding of the development process and demonstrated experience in the clinical supplies area is required.
-Knowledge of GMP label creation and packaging operations to support clinical trials.
-Ability to work independently with minimal supervision. Ability to prioritize tasks and work in a flexible manner with some supervisory input.
-Should be detailed oriented.
-Basic PC operation (Email, Windows, word processing, database, spreadsheet applications)
-Ability to write documents
-Good interpersonal skills.
-Ability to adhere to written instructions (i.e. follow the rules and guidelines of the department).
-Developing sound judgment, decision-making skills and strong organizational skills. Beginning to influence others.
-Must exhibit strong communication, negotiation, and interpersonal skills.
-Ability to function on a high performance team.
-Ability to listen and follow verbal instructions.
-Ability to perform trouble shooting and problem solving with supervision. Ability to follow-up and evaluate problems appropriately.
-Ability to double-check the work of others for accuracy.
-Ability to build team spirit.
-Participate and support implementation of change.

About the Company

Integrated Resources, Inc

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