QC Materials Analyst

MeiraGTx; London; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the gene therapy field is seeking a qualified professional to manage incoming materials in compliance with good manufacturing practices. The successful candidate will ensure quality and compliance for the aseptic manufacturing of advanced therapy medicinal products, contributing significantly to the operational success of the team.

Qualifications

• Minimum 1 year experience in a GxP environment.
• Experience with quality documentation required.

Responsibilities

• Ensure compliance with Good Manufacturing Practice (GMP).

Skills

Attention to detail

Problem solving

Quality management

Planning/organizing

Motivation

Communication

Tools

Microsoft Office

Job description

Your mission

Purpose of Job

To manage incoming materials and support Good Manufacturing Practice (GMP) compliant activities for the QC release of products and incoming materials. Support the QC Materials Team in other activities as requested.

Job Description

Major Activities

• Perform inspection of incoming materials, following SOPs and GMP practices to ensure seamless supply of materials to support the aseptic manufacture of ATMP products.
• Monitor the material inspection programme to ensure materials are suitable for the manufacture of gene therapy products to the required standards.
• Physically inspect 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 to meet GMP requirements.
• Ensure adequate control of the material status for release or rejection.
• Comply with MeiraGTx procedures, including health and safety and GMP.
• Ensure all equipment used is calibrated/maintained and in line with SOPs.
• Identify and report procedural problems and deviations.
• Participate in planning duties to ensure the facility is acceptable and customers receive products on time and in full.
• Perform any other duties/projects within the skills and ability of the post holder.
• Identify and support method/technology improvement activities and facilitate implementation into the microbiology department.
• Ensure that own work complies with GMP, Data Integrity, and Good Documentation Practice (GDP), undertaken in accordance with applicable procedures.
• Ensure own training is undertaken in a timely and GMP-compliant manner before tasks are undertaken.
• Ensure that any GMP documentation assigned (e.g., issues, CAPAs, change controls, BMRs, audit/inspection actions) is closed timely and in a Right First Time (RFT) state.

Key Performance Indicators

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

Key Job Competencies

• Experience working within a GMP manufacturing environment.
• Quality management—seeking ways to improve and promote quality; demonstrates accuracy and thoroughness.
• 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 standards of excellence.
• Planning/organizing—prioritizes and plans work activities; uses time efficiently.
• Professionalism—approaches others tactfully; 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 seeks 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 year experience working in a GxP environment.
• Experience with quality documentation.
• Proficiency in Microsoft Office software (Word, Excel, PowerPoint) preferred.

Why us?