Job Title: Senior Quality Assurance Technician
Location: Chesterfield, S44 6AE
Salary: £28,000 - £30,000
Working Pattern: Monday to Friday, with 2 to 3 day working from home
Hours: 40
Type of Role: Permanent

ABOUT THE ROLE:

The Senior QA Technician operates within the QA Department to help ensure compliance of company operations with applicable legislation and regulatory requirements.

ROLES AND RESPONSIBILITIES:

Quality Management System (QMS)

• Writing and updating standard operating procedures (SOPs) and Work Instructions (WIs).
• Creating training materials including presentations, videos, and competency assessments to be shared with company employees.
• Completing QMS records including deviation investigations, risk assessments, change controls, and CAPAs (Corrective Actions and Preventative Actions).
• Working alongside other departments to manage the implementation of planned changes.
• Performing appropriate due diligence of suppliers and customers of medicinal products.
• Participating in regular meetings with service providers to discuss the potential for continual improvements.
• Helping collate metrics on Key Performance Indicators to support routine trending and Quality Management Review meetings.
• Reviewing documents and records in the Quality Management System.
• Performing ad-hoc tasks relating to Quality Functions, as requested.

Products

• Investigating customer complaints.
• Monitoring the sales patterns of high-risk products with abuse potential.
• Detecting, reporting, and investigating signs of illegal activity where products may be falsified, counterfeit, stolen, or diverted.
• Coordinating medicinal product recalls in an organised and timely manner to ensure patients do not receive medicines with possible defects.

Facility and Software

• Performing seasonal temperature mapping studies (facility + vehicles).
• Writing and executing test scripts to validate computer systems.
• Qualifying equipment and performing challenge testing under different failure modes.

Inspections/Audits

• Performing audits on internal systems, processes, and departments according to an approved schedule of self-inspections.
• Performing monthly self-inspections at the ‘other sites’ named on page 1. A company pool car will be provided for all commuting to these premises.