Gene Therapy QC Scientist (GMP)

The QC Analytical Scientist is responsible for the testing of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements.

Major Activities

• 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.

Additional Activities

• 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 Laboratories to GMP standards.
• Analytical - Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to complement data.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skilfully; 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 - Prioritises 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.

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.

Job Responsibilities

• Compliance with GMP.

Job Background

• 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.