QA Auditor

We are seeking to appoint a QA Auditor to join our team and make a positive impact in a growing and progressive CRO. This is a fantastic opportunity to join an experienced QA team in an inclusive company that put the needs and wellbeing of their people first, and who deliver exceptional service. 

The focus of the job is to manage system, study and vendor audits and other QA activities to match customer expectations. You will also be involved with the rest of the QA team in the management of quality issues arising and the general QMS over all MAC’s operations so you’ll need to have a helpful disposition, ability to problem solve and be motivated to improve the service.

You will be largely working from home, with periodic visits to predominately UK sites which means we’re looking for candidates that have a full driving licence and access to their own transport. 

This role is home based and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide). By proceeding with your application, you are confirming you are able to do this.

• A degree in science or science-related subject
• Ability to understand, after training, a Quality Management System covering clinical trials and related activities/regulations
• Good interpersonal skills
• The ability to write clear, concise and grammatically sound reports
• Good attention to detail and organisational ability
• A logical approach to problem analysis and solutions
• An ability, after training, to grade audit findings appropriately and manage their workflow
• Sufficient initiative to be able to work alone and with a team
• Good skills with MS Office
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RESPONSIBILITIES:

• Management of quality issues
• Organisation and performance of Vendor Audits with SMEs and QA colleagues
• Performance of Study and System audits in all MAC operations relating to clinical trials, particularly in GCP-regulated arenas.
• Tracking audits, through generation and responses, to closedown.
• Managing and assisting with the hosting of external audits from clients or regulators.
• Maintenance of the Approved Vendor List
• Management of Archives
• Assisting the QA Manager and Head of QA in facilitating quality improvements and quality training.
• Keeping aware of new quality regulations, trends and guidelines.

General

• Compliance with MAC health and Safety policy
• Compliance with MAC policy on equality and diversity
• To maintain professional qualifications required for the role, including continuous personal development
• To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice, or other applicable regulations/guidelines
• To work according to MAC SOPs, guidelines and policies
• To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business-related data.
• To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure job role is efficiently carried out
• To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:

Periodic, frequent visits to other MAC sites or suppliers, primarily in the North of England and the Midlands.

 BENEFITS:

• Health Insurance
• Eye Care Vouchers
• Cycle to work scheme
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.