Quality Assurance Associate

• Job title: Associate Principal QA Specialist
• Location: Slough
• Contract Length: 12 months
• Working Hours: 37.5 hours/week
• Pay Rate: up to £32.76 p/h DOE

About the Role

• Provide QA review and oversight for various studies and activities.
• Support a culture of quality and continuous improvement within QC and Development Services.
• Support Operations to ensure ongoing compliance with GMP.
• Manage and support GMP issues through QMS processes, site governance and senior QA leadership.
• Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site.
• Support senior QA leadership in driving continuous improvement and ensuring processes are ‘fit for purpose’.
• Ensure compliance with GMP requirements within Development Services.
• Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements.

Key Responsibilities

• Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records.
• Review QA activities for MSAT studies, pilot studies, and Development Services.
• Review QC activities including method validation, reference standards and stability studies.
• Manage and escalate critical compliance issues through the QMS.
• Conduct audit trail reviews.
• Perform area walkthroughs to identify and resolve non-compliance.
• Audit raw data, protocols and validation reports for GMP compliance.
• Maintain and promote audit readiness.
• Ensure protocols and validation reports are approved according to project schedules.
• Lead process audits and support GMP audit activities.
• Identify and participate in continuous improvement initiatives.
• Support quality governance via Local Quality Councils and project meetings.
• Provide QA SME support for Operations, QC, MSAT and Development Services.
• Mentor and coach business partners in GMP practices.
• Advise scientists on documentation and follow-up expectations.
• Provide out-of-hours QA support where required.
• Act as a GMP SME enforcing site quality processes
• Perform additional duties as assigned.

Skills/education

• Education/Degree: Field of Study Scientific
• Work Experience: Quality (QA or QC) Level- Advanced - 5-10 years
• Top three must have experience: QA Manufacturing experience, TrackWise records experience (Deviations, Change controls, CAPA’s, investigations) OOS investigations
• Nice to have experience: Audit experience