Our Client is an independently owned and operated company that works exclusively with clinical trial materials. The UK site provides secondary packaging (labeling and kitting) of any dosage form into plain packaging to ensure blinding of supplies for clinical trials, and storage and distribution of clinical materials for use in clinical trials. Their facility near Reading serves as the distribution hub for the packaged clinical trial materials to Europe and the rest of world.
They are now seeking a QC Associate to join their dynamic team. This position is a full-time permanent role reporting to the QA Manager / Responsible Person and will be based near Reading, Berkshire.
Our Client will also consider a new Science Graduate (or similar / equivalent) for this role with limited experience who has a desire to develop a career in QC within the Pharmaceutical / Clinical Supplies Industry
Job Purpose
This position is responsible for completing the inspection of all incoming materials and for the tasks and responsibilities listed below to coordinate the movement of staged materials, perform packaging room inspections, and to maintain supplies and forms. Work closely with Quality team in the maintenance of the quality systems.
Key Areas of Responsibility

• Maintain work area in accordance with GMPs
• Perform the incoming QC inspection of materials, including:
  
  • Drug products
  • Medical devices
  • Primary packaging components
  • Secondary packaging components
  • Label stock
  • Clinical labels
• Assist with end of job inspections for batch records
• Assist with development of Standard Operating Procedures, data capture forms and other associated QA/QC documentation
• Assemble appropriate materials as specified on the Batch Record
• Perform room clearance inspections before delivery of product to packaging rooms.
• Perform ongoing room inspections to verify that instructions, as listed in the Batch Records, are being followed
• Respond to any requests, comments or questions from the packaging room personnel
• Verify staging of materials
• Perform End of Job Inspections
• Replenish QC-issued forms for use in Packaging Rooms
• Replenish Supervisor-issued forms for use in Packaging Rooms
• Maintain organization of all retention samples
• Execute weekly reviews of all log books to verify cleans and proper entries
• Verify materials pulled for Interoffice Shipping Requests
• Enter and verify data in the Inventory Control System
• Assist in the maintenance of quality systems including NCEs, change control, batch record archiving
• Review facility temperature records
• Assist with Quality metrics
• Assist with the resolution of quality issues, where appropriate
• Comply with Company health and safety requirements
• Other duties as required.

Qualifications and Experience

• BSc in a scientific subject OR equivalent relevant experience
• Our Client will also consider a New Science Graduate (or similar / equivalent) for this role with limited experience who has a desire to develop a career in QC within the Pharmaceutical / Clinical Supplies Industry
• Strong understanding of GMP
• Familiarity with the pharmaceutical industry
• Excellent interpersonal skills
• Excellent reading and writing skills
• Excellent communication skills
• English literacy
• Excellent mathematical skills
• Computer literacy skills
• Attention to detail
• Good planning and organizational skills to meet required timelines
• Able to accept responsibility and be pro-active within defined limits
• Able to respond quickly and build good relationships internally and if required externally

In return our client is offering a competitive package for the successful Candidate including a basic salary of GBP25,000 - GBP32,000 per annum plus benefits. (Salary is negotiable dependent on experience)

Please send your C.V and covering letter to Lorraine Roger, Director at Atom Recruitment Ltd.