QC Associate - Clinical Trial Supplies

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 the world.

They are now seeking a QC Associate to join their dynamic team. This position is a full time permanent role reporting to the Senior QA Manager and will be site based near Reading, Berkshire.

Our Client will 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 OR candidates with relevant QC experience.

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 cGMPs. Perform the incoming QC inspection of materials, including: Drug products / Medical devices / Primary packaging components / Secondary packaging components / Label stock. Verify staging of 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 and escalate to QA if required. Replenish QC-issued forms for use in Packaging Rooms
  
  
• Replenish Supervisor-issued forms for use in Packaging Rooms. Perform end of job inspections for batch records. Enter and verify data in the Inventory Control System
  
  
• Perform quality control activities of Just In Time Shipments
  
  
• Maintain organization of all retention samples. Verify Returns for Accountability. Execute weekly reviews of all logbooks to verify cleans and proper entries
  
  
• Participates in internal, supplier, client and MHRA audits as needed
  
  
• Assists with the generation, revision and review of Standard Operating Procedures, Data Capture Forms and other GMP/GDP documents. Responsible for internal SOP training of all employees, keeping track of their training and maintaining their training records, positions descriptions and maintaining training courses
  
  
• QA Management of SOP’s, Forms, WI’s, Position Description’s and Training Presentation’s on electronic system. Responsible for reviewing and filing cycle count documentation. Responsible for review of products that are new to determine if they are acceptable for handling or use
  
  
• Assists the Qualified Person in the preparation of QP Declarations and QP Certificates. This will involve the creation of supply chain diagrams, product specification files, review of regulatory submission documents and review of manufacturing batch records. Assists with the distribution of Client Qualification Questionnaires and for maintaining the Qualified Clients List
  
  
• Assist with the tracking and updating of product expiration dates and authorization of materials for destruction. Assist in the maintenance of quality systems including NCEs, change control, batch record archiving
  
  
• Maintains EU GMP/GDP documentation storage of all pertinent documents, including scanning, filing and archiving (manually & electronically)
  
  
• Assist with Quality metrics tracking. Assist with the resolution of quality issues, where appropriate. Provides support for release of clinical labels. Assist with updating product expiration dates
  
  Qualifications and Experience
  
  
• BSc in a scientific subject OR equivalent relevant experience
  
  
• Our Client will 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 OR candidates with relevant QC experience
  
  
• Strong understanding of cGMP
  
  
• Familiarity with the pharmaceutical industry
  
  
• Previous successful Packaging Room experience would be beneficial
  
  
• 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 salary of c£27,000 per annum basic plus benefits for the successful Candidate. (Salary is negotiable dependent on experience and more may be available).
  
  Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd