DEPARTMENT: QUALITY CONTROL
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – QC MANAGER
Purpose of Job
The QC Analytics Technician is responsible for the testing of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements.
- The testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule
- Support testing requirements for the management of the facility including support of the environmental monitoring schedule
- Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with the test schedule
- Record of out of specifications, non-conformances, investigations, analysis and implementation of corrective action(s) as applicable
- Assistance with the development and updating of SOPs and laboratory documentation
- Part of the Quality Control team, maintain the flow of information, ensuring appropriate communications are passed and information folders are maintained with most recent version/communication
- Ensure all training is undertaken in a timely manner as required to perform required activities. Support any training activities of other employees where required.
- Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits
- Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced.
- Support any external or internal audits where required
- Support with all reasonable managerial requests and ad-hoc tasks.
- Work in a team manner with Production personnel
- Assist in the introduction of new analytical methodology for testing gene therapy products
Key Performance Indicators
- All testing performed meets QC KPI requirements
- Internal quality control audits
- Plan, manage and record training effectively
Key Job Competencies
- QC testing of products to GMP requirements
- Maintenance of Laboraotires to GMP standards
- Analytical – Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures.
- Motivation – 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.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; 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.
- Compliance with GMP
- Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics,).
- Demonstrate knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.
- Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.