QA MANAGER
Closing date for applications: 20 February 2025
We are seeking to appoint a QA Manager (Fixed Term Contract (FTC)) to join our laboratory team in Manchester 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.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
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 devel-opment.
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 mem-bers 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
BENEFITS:
Health Insurance
Free onsite parking
25 days annual leave (increasing in increments to 30 days after 6 years' service)
Your birthday off work
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We invite 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 maccareers@macplc.com 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.
Salary: Competitive + Negotiable £ Apply Now
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