QC Support Specialist – £29,950pa

Our client a global biotech company based in Speke are looking for a QC Support Specialist to support the QC Compliance and Improvement Manger in providing compliance support across QC activities.

This is a temporary role to start ASAP until the end of June with a strong likelihood of being extended for up to 1 year or more.
Hours of work are Monday to Thursday 8am – 4.45pm and Fridays 8am – 1pm. There is hybrid working available where you would be required to be in the office 3 days per week.

Key Responsibilities:

• Work closely with the labs to lead Deviations, CAPA’s and Change Controls through to on time completion
• Participate in lab improvement projects
• To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment are applied in all activities, in accordance with current regulations and procedures
• Ensure QC compliance with the companies Policies
• Support QC labs with respect to sample delivery from across the Liverpool sites to the labs in a timely manner
• Keep oversight of and facilitate on time completion of DR’s, CAPA’s, Change Controls and SOP Updates
• Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review.

Key Skills/Experience:

• cGMP background in the pharmaceutical industry
• Knowledge and understanding of Lean Lab principles
• Good understanding of the QC labs
• Knowledge of continuous improvement techniques and advanced root cause analysis techniques
• Report writing skills
• Proven time management skills
• Proven communication skills both written and verbal
• Minimum of 3 years in a QC role