Quality Control Analyst

MeiraGTx; Shannon; On-site; EUR 40,000 - 60,000; Full time

Job summary

MeiraGTx in Shannon, Ireland, is seeking a QC Analyst to support GMP-compliant analytical testing and product release for plasmid and gene therapy programs. You will execute routine assays, liaise with external laboratories, maintain lab equipment, and help sustain the Quality Management System and data integrity.

The role requires a scientific degree and hands-on GMP experience, with emphasis on accuracy, problem solving and teamwork in a fast-paced environment.

Qualifications

• BSc in a scientific discipline; GMP experience preferred.
• Minimum 2 years in GMP environments.
• Experience with gene therapy and/or biologics; qPCR and cell culture focus.
• Proficiency in Microsoft Office (Word/Excel).

Responsibilities

• Execute routine analytical testing to support timely release.
• Support testing at external contract labs for materials and final product.
• Operate and maintain laboratory equipment; ensure calibration.
• Record Out-of-Specifications, non-conformances, investigations and CAPAs.
• Assist with SOPs and laboratory documentation; maintain data integrity.

Skills

GMP experience

qPCR

Cell culture

Flow cytometry

HPLC

Western blot

SDS-PAGE

DNA extraction

Spectrophotometry

MS Office

Education

BSc in science (Biochemistry/Chemistry)

Job description

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 plasmid and gene therapy products.

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.
• 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; particular focus on qPCR and cell cultures. Other areasof benefitHPLC, 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.