We have an exciting opportunity for a QC Analyst to work for our global pharmaceutical client based in Milton Keynes. The role is a full–time temporary contract role signed off until the end of December 2024 with a possible extension. You will be required to work 37.5 hours per week (Monday Friday) and our client offers an hourly rate of up to GBP18ph depending on experience, plus 25 days holiday pro rata.

The QC Analyst will be enthusiastic and dedicated to:

• To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.
• Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio–assays, such as ELISA coats, ELISA conjugates, reference sera, toxins etc.

Key Accountabilities and Duties

• Expertise in Immunology techniques such as ELISA s, haemagglutination tests, antigen mass assay is essential.
• Biology/Microbiology method validation / improvements and test transfer between labs/sites.
• Production and Validation and of biomaterials used in in–process and final product testing.
• Understanding of microbiology techniques is beneficial.
• Support in change management for introduction of new / improved methods and validation of new equipment.
• Be able to produce technical documents such as protocols, testing and execution plans and final reports.
• Update SOP s and other GMP documents ensuring they are current and relevant.
• Ability to work on several projects simultaneously and be able to prioritise.
• Reporting and communication of results to stakeholders. Liaise with several departments – technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
• The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.
• Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
• Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.
• Interact closely with fellow scientists and global/regional colleagues within own and other departments.
• Work in a multi–disciplinary and international team and environment.

Other responsibilities

• Comply with Standard Operational Procedures (SOP s), GMP, ESH procedures and corporate policies and process improvements.
• Maintain all documentation and training records as per GMP requirements.
• To comply with company s health and safety practices and procedures.
• Ensure positive, timely and effective communication with team members and internal customers.

Person Specification

Knowledge

Good understanding and working knowledge of GMP Quality Systems

Technical expertise in ELISA s and other immunology techniques, including microbiology techniques.

Experience

Minimum 3 years of experience with excellent understanding of testing within a laboratory environment

Laboratory investigations

Validation and method development

Previous roles include interaction with other operations and technical roles

Skills & Abilities

Proficient in use of Microsoft Office especially Excel and Word.

Good Protocol and Report writing skills.

Ability to troubleshoot to resolve issues

Basic Statistical understanding Knowledge such as Minitab Statistical software

Personal Attributes

• Ideal candidate should be self–motivated, hardworking, be able to work under pressure to deliver success within set timelines and hold a positive mindset
• Excellent organisational and planning skills and a flexible approach to changing priorities
• Able to communicate concise technical information with clarity, at all levels and across all functions
• Able to assist in fact finding discussions
• Attention to detail

Qualifications

Degree in Biology/Microbiology (possibly a phD )

Other Requirements

Cross functional work experience

Demonstrated scientific problem–solving capabilities

Full UK driving license