QC Materials Analyst - 12 month Maternity Cover

Major Activities

• Perform inspection of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
• Monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards.
• Physical inspection of raw materials. Ensure the warehouse storage environment is acceptable for the materials being inspected (Can be multiple warehouse locations).
• Coordinate incoming material testing where required.
• Maintain all incoming material documentation meets GMP requirements.
• Ensure adequate control of the material status for release or Reject.
• Comply with MeiraGTx procedures including Health and safety and GMP.
• To ensure all equipment used is calibrated/maintained and in line with SOP’s.
• Identify and report procedural problems and deviations.
• Perform and support environmental monitoring activities for the sampling room, in line with GMP requirements, ensuring results are recorded and reported.
• Perform sampling of incoming raw materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product.
• Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full.
• Any other duties/projects within the skills and ability of the post holder.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.

Key Performance Indicators

• HR process compliance.
• Material release KPIs.
• GMP compliance.
• Data integrity.
   
  

Key Job Competencies

• Experience of working within a GMP manufacturing environment.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• A high Level of attention to detail.
• Problem Solving - Identifies and resolves problems in a timely manner; able to gather information; develops alternative solutions; works well in group problem solving situations.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
• Physical & mental requirements - occasional lifting; the noise level in the work environment is usually moderate.

Job Responsibilities

• Compliance with GMP.
   
  

Job Background

• Minimum 1 years experience working in a GxP environment.
• Experience of quality documentation.
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.