Junior Quality Assurance Officer

Reporting to the Quality Manager and assisting with day to day duties of the Quality Department

This is an exciting opportunity to become a key member of the Quality Team within a niche biotechnology company that is enjoying significant success and expansion

ROLE

• Assist with the development and evaluation of the policies and procedures within the Quality Department
• Assist the Quality Manager with determining, negotiating and agreeing on in-house quality procedures, standards and specifications
• Assist with the drafting and reviewing of the company’s Standard Operating Procedures (SOPs)
• Perform compliance audits of study plans, data and reports
• Attend inspections undertaken by regulatory bodies or customers
• Be aware of the impact of regulatory risk on the business and report any signs of risk to your line manager
• Carry out self-inspection audits alongside the quality manager and assist with reporting any findings
• Partake in relevant change controls and CAP.A’s processes
• Assist the Quality Department with Gap Analysis reporting and meetings
• Be aware of the production process and its impact on quality
• Maintain GMP compliance
• Assist the Quality Manager with specifying quality requirements of materials with suppliers
• Conduct reviews of suppliers alongside the Quality Manager and report findings
• Conduct research into regulatory rules and requirements and present the findings to the Quality Manager
• Write protocol reports for validation or trial purposes

REQUIRED

• Scientific qualifications are desirable, but are not essential for this role
• Experience of working to a quality based system, preferably GMP is essential
• Good understanding of equipment design, validation and change control process
• Ability to write concisely in plain English

REMUNERATION 

A basic starting salary of £22K

RESPOND

To learn more about this role telephone Terry Blaney on 01580 211221 or e-mail your application, including your current CV to terry@arxconsultancy.com