Your mission

As a QC Analyst, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)-compliant activities within QC to support the manufacture and release of gene therapy products.

Job Description

Major Activities

• Execute routine analytical testing to support timely release of product.
• Support testing at external contract labs for raw materials and final product.
• Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with test schedule.
• Record Out-of-Specification, non-conformances, investigations and implementation of corrective action(s) where applicable.
• Assistance with the development and updating of SOPs and laboratory documentation.
• Ensure all training is undertaken in a timely manner as required to perform activities designated.
• 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.
• Execution of equipment qualification and method validation/transfer when required.
• Propose and/or support the development and implementation of continuous improvement programs.
• 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 are closed timely and in a RFT state.

Key Performance Indicators

• Adherance to timelines.

Key Job Competencies

• Experience of working within a quality environment.
• High level of attention to detail.
• 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.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• 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 Experience / Professional Background

• BSc in a scientific discipline e.g. Biochemistry, Chemistry.
• Minimum 2 years’ experience working in a GMP environment.
• Experience in working with gene therapy and/or biologics methods e.g. qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction, Spectrophotometry.
• Experience with mammalian cell culture and/or flow cytometry preferred.
• Proficiency in Microsoft Office software preferred, specifically Word, Excel and PowerPoint.
• Wants to learn and have a natural curiosity to understand systems and processes.
• Ability to work in a fast-paced environment essential.

Why us?