Laboratory QA Manager (FTC)

We are seeking to appoint a QA Manager (Fixed Term Contract (FTC)) to join our laboratory team and cover maternity leave for up to 12 months.

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 oversee Quality Assurance within our safety and bioanalysis laboratories, to ensure the highest standards of data integrity and safety and maintain existing ISO 17025, GLP and GCP standards. The successful candidate will be experienced in these standards and able to work closely with our laboratory team, reporting to the Head of Quality Assurance.

You will be regularly conducting audits and following them up until completion. Other duties include a degree of document control and training in applicable standards/guidelines.

(Hybrid role with four days working from home and one day onsite at Manchester - Salary around £38k)

This role includes working from home 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), please confirm you are able to do this before proceeding with your application. 

• Several years’ experience in Quality Assurance within safety/bioanalytical laboratories, especially those with ISO17025 and/or GLP compliance supporting clinical trials.
• Familiar with ISO7025 and GLP or GCLP
• Knowledge and experience in conduction CAPA
• The ability to conduct, report and follow-up laboratory QA audits and other QA activities within the CRO business.
• Excellent interpersonal skills, both written and spoken
• A basic understanding of Computer Systems Validation and related IT infrastructure systems and processes.
• Ability to communicate and negotiate with internal stakeholders and Sponsors effectively
• The ability to write clear and concise reports
• Good attention to detail and organisational ability
• A logical approach to problem analysis and solutions
• An ability to grade audit/report findings appropriately and manage their workflow
• Excellent initiative to be able to work alone and with a team
• Good skills with MS Office
• A friendly and helpful disposition

RESPONSIBILITIES:

• Performing and management of study, system, facility, witness, vendor and other types of audits.
• Participating in scientific review for new study requests, providing quality expertise and input for the study requirements as and when required
• Working with operational staff to help develop SOPs for all laboratory functions
• Monitoring external proficiency testing program as required; facilitating corrective action promptly when results are unsatisfactory.
• Management of audit and other QA documentation and follow-up of findings
• Liaising with Sponsors and other staff as necessary, to ensure efficiency and customer satisfaction
• Keeping updated with the latest regulations and guidelines relevant to the role
• Management of quality issues arising
• Management of any applicable risk assessments
• Hosting or assisting with external sponsor/regulator audits as required
• Proactive in oversight and development of the QMS
• Compliance with MAC health and Safety policy
• Compliance with MAC policy on equality and diversity
• To maintain any professional qualifications required for the role, including continuous personal development.
• 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 the 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

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



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.