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Quality Control Support Associate

2 months ago

Liverpool, Liverpool, United Kingdom Russell Tobin Full time
Position Overview

Quality Control Support Associate - Contract Position - Competitive Hourly Rate

Objective:

This role assists the Quality Control Compliance and Enhancement Manager in delivering compliance assistance throughout Quality Control operations.

The individual will be accountable for all tasks related to quality assurance and adherence to relevant regulatory standards; performing audits and evaluating data and documentation. Familiarity with standard concepts, practices, and procedures in the field is essential.

Collaboration with laboratory teams is crucial to effectively manage Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls to ensure timely resolution.

Engagement in laboratory enhancement initiatives is expected.

It is imperative to uphold the highest standards of current Good Manufacturing Practices (cGMP), cleanliness, health, safety, and environmental protocols in all tasks, in line with existing regulations and procedures.

Ensure compliance with organizational policies within Quality Control.

Assist Quality Control laboratories in the prompt delivery of samples from various sites.

Maintain oversight and facilitate the timely completion of Deviations, CAPAs, Change Controls, and Standard Operating Procedure (SOP) updates.

Responsible for compiling monthly and annual reports for Environmental Monitoring, Bioburden, and Endotoxin results, including comprehensive product reviews.

Key Responsibilities:

  • Assist Quality Control Managers in aligning planning and resources with project and supply chain forecasts.
  • Contribute to innovative solutions and improvement initiatives across Quality Control. Participate in site enhancement projects as necessary to drive quality decisions and provide technical support.
  • Ensure the timely execution of Deviations and CAPAs, and the advancement of Change Controls to support Quality Control laboratories. Ensure SOP updates are completed as needed for continuous improvement or scheduled reviews.
  • Track, trend, and consistently display critical Quality Control KPIs, Health, Safety, and Environmental (HSE) activities, and cGMP compliance.
  • Oversee Quality Control capital expenditure projects.

Accountability:

Gather data related to site and organizational changes that may affect the efficient operation of laboratories.

Manage the completion of Deviations, CAPAs, Change Controls, and SOP updates in close collaboration with Quality Control laboratories.

Participate in and present at relevant review boards.

Submit and manage capital expenditure project proposals.

Maintain Quality Control performance metrics.

Engage in problem-solving initiatives.

Qualifications & Skills:

• Background in cGMP within the pharmaceutical sector

• Understanding of Lean Laboratory principles

• Comprehensive knowledge of Quality Control laboratories, including experience with Quality Control and Microbiological testing methodologies

• Familiarity with continuous improvement strategies and advanced root cause analysis techniques

• Proficient report writing capabilities