QC Microbiology Analyst

MeiraGTx; Greater London; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading biotechnology company seeks a QC Microbiology Analyst to ensure compliance with GMP standards and perform environmental monitoring in their aseptic manufacturing facility. The role involves testing, analysis, and collaboration with various teams to maintain quality and compliance.

Qualifications

• Experience in pharmaceutical or similar regulated industry.
• Knowledge of GMP/GLP regulations preferred.

Responsibilities

• Performs environmental monitoring and QC testing.
• Maintains GMP compliance and laboratory equipment.
• Records and reports out-of-specification results.

Skills

Problem Solving

Analytical

Motivation

Professionalism

Oral Communication

Written Communication

Education

BSc in Microbiology

Tools

Microsoft Office

Job description

Join to apply for the QC Microbiology Analyst role at MeiraGTx

Join to apply for the QC Microbiology Analyst role at MeiraGTx

The QC Microbiology Analyst position works within the Quality Control team. The QC Microbiology Analyst is responsible for the microbiology environment monitoring sampling of the facility, incubation and analysis of microbiology samples, QC testing and general facility audit readiness.

Job Description

Major Activities

• Performs environmental monitoring of the MeiraGTx aseptic manufacturing facility.
• Ensures all testing is completed as per the Environmental Monitoring programme.
• Adheres to aseptic technique when working in controlled facilities as well as QC laboratories.
• Performs analysis of the environmental monitoring samples.
• Records and reports out-of-specification results and implements corrective actions as applicable.
• Maintains QC facilities to meet GMP requirements, and conducts necessary checks to support any health authority, customer/stakeholders site visits.
• Ensure the laboratory paperwork and operations are fully GMP compliant.
• Performs QC testing of materials and products as required.
• Operates and maintains laboratory equipment, ensuring all equipment is calibrated and suitable for use as applicable.
• Handles or disposes of hazardous materials safely and in accordance with procedures.
• Supports maintaining the Quality Management System and control of documents, ensuring the data integrity of all data produced.
• Supports with all reasonable managerial requests and ad-hoc tasks.
• Works closely and collaboratively with the Manufacturing, Engineering, QA and Supply Chain teams.
• Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, BMR’s, Protocols, Guidance’s, etc.
• Ensure own training is undertaken in a timely and GMP-compliant manner before the task is undertaken.
• Ensure own KPI’s, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines

Key Performance Indicators

• All testing performed meets QC KPI requirements.
• Environmental monitoring requirements for the facility are achieved to ensure manufacturing conditions meet aseptic manufacturing standards are met.
• Environmental monitoring OOS and OOT are investigated within established timelines.
• Ensure all training is undertaken in a timely manner as required for each activity.
• Internal QC audits performed.
• Quality Events are dealt with in a timely manner.
• QC GMP testing is aseptic manufacturing facilities and products.
• 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.
• Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data.
• Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Cost consciousness – Works within the approved budget.
• 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; has a keen eye for aseptic behavior.
• 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.

Job Background

BSc in Microbiology or equivalent relevant work experience in pharmaceutical or other similar regulated industry (i.e. biologics or medical devices).

Preferred knowledge of GMP/GLP regulations, FDA regulations etc

Proficiency in Microsoft Office.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing, Analyst, and Science

• Industries

  Biotechnology, Manufacturing, and Pharmaceutical Manufacturing

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