QC Team Leader
DEPARTMENT: QUALITY CONTROL
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – QC MANAGER
Purpose of Job
The main purpose of the Quality Control (QC) team leader is to manage a team of QC analytical scientist/analyst’s for the QC release testing and stability testing of gene therapy products and associated materials used for manufacturing to EU and US GMP requirements.
- Provide line management to members of the QC department to contribute to the overall group objectives
- Overseeing the Quality Control department to support the quality control release testing of gene therapy products and associated materials
- Develop and manage the site testing schedule to ensure testing is complete by the required timelines
- Plan and assign work to the team to achieve the most efficient use of personnel and resources.
- Manage the stability programme and ensure testing is complete within the required test windows.
- Manage the stability chambers to ensure samples are integral and available for stability test points
- Support any incoming material testing to ensure adequate supply of ateirals
- Ensure OOS events are reported immediately and appropriately investigated
- Ensure all direct reports or persons are fully trained for tasks they perform and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated and reported.
- Support the development, qualitication, validation and implementation of analytical methods within QC
- Ensure all equipment is within calibrartion and operational to support the testing schedule
- Contribute to the training and development of your reports
- Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
- Contribute to cross departmental activities and providing expert advice and technical input where needed.
- Assure the data integrity of all activities performed.
- Ensure area compliance with Quality, Safety and Environmental systems and procedures.
Analytical QC department
- Perform analytical testing, following SOPs and GMP practices to support QC release testing of gene therapy products.
- Support the on site stability programme to assign life to the gene therapy products Manufature.
- Carrying out the day-to-day monitoring of the GMP facility to ensure that the facility is operating in a compliant and safe manner.
- Proficient in the use of aseptic manufacturing techniques and act as the subject matter expert.
- Operate to appropriate GMP practices within a clean room environment to assure continued compliance within those areas.
- Perform routine cleaning of the manufacturing facility.
- Ensure that the MeiraGTx manufacturing facility and storage areas are maintained in a fit-for-purpose state.
- Conduct regular stock checks and assist in the maintenance of the stock inventory.
- 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.
- 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.
- Identify and support method/technology improvement activities and facilitate implementation into the microbiology department.
Key Performance Indicators
- HR process compliance
- Staff turnover rate
- GMP compliance
- Data integrity
Key Job Competencies
- Quality control knowledge and experience to organise and perform QC testing to support the release of safe and effective product.
- Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations
- Leadership – exhibits confidence in self and others when leading a team of people and managing processes.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- 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; plans for additional resources; sets goals and objectives
- 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.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- 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.
- Team of Quality control Scientists/technicians
- Compliance with GMP
- Supervisory and/or management experience of people and/or processes.
- Several years experience of operating in or managing a team within a Quality control function
- Degree in a relevant scientific discipline elements (or equivalent) or relevant experience.
- Application of GMP
- Experience of document management/QMS systems.
- Need to be numerate
- Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.