Quality Assurance Specialist

Position: QA Specialist

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Job Description:

We are currently expanding our team and are looking for a QA Specialist to provide full-time support for coordinating deviation investigations, ensuring timely closure of quality events, and maintaining compliance with site procedures and regulatory expectations.

Key Responsibilities:

• Lead end-to-end deviation investigations for engineering-related events, ensuring investigations are completed in accordance with quality management system requirements and established timelines.
• Collaborate closely with subject matter experts (SMEs) across Engineering, Production, MSAT, Validation, and Quality functions to gather information, assess impact, and determine appropriate investigation strategies.
• Assess the effectiveness of corrective and preventive actions (CAPAs) and provide recommendations to prevent recurrence of identified issues.
• Track and coordinate deviation lifecycle milestones, ensuring progress is communicated and escalations are raised where necessary.
• Support engineering teams in identifying trends across deviations, CAPAs, and recurring issues to drive operational excellence and continuous improvement.
• Maintain accurate documentation within electronic quality management systems and ensure all records are inspection-ready.
• Participate in investigations related to equipment performance, maintenance activities, utilities systems, process interruptions, automation issues, and engineering projects as required.

Requirements:

• Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries.
• Experience supporting internal audits, regulatory inspections, and continuous improvement initiatives.
• Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels

What's Next

If you are interested in applying for this position, please send an email to [Confidential Information].

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role