Associate Principal QA Specialist

Job Title: Principal QA Specialist – Global Biopharmaceutical Contract: 12 months Location: Slough (onsite) – potential for hybrid after training complete Salary: £31.99 PAYE, £40.47 Umbrella per hour (Inside IR35) Hours: 37.5 hours per week Reports to position * QA Manager (QA Technical Support) Job Title * Associate Principal QA Specialist, QA Technical Operations Primary Location * Slough Role Purpose & Scope * (why does this job exist and what scope does it cover?) Support Operations to ensure Compliance to GMP Manage and support GMP issues through QMS processes, site governance and senior QA leadership. Act as a GMP SME by implementing, managing and enforcing quality processes on site. Supporting Senior QA leadership to drive continuous improvement and ‘fitness for purpose’. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and our clients Customer expectations Key Responsibilities * To provide shoulder to shoulder review, approval and support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations, OOS. Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs To actively identify, suggest and participate in continuous improvement activities Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality culture Maintain and promote a state of audit readiness Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects Provide QA SME support at departmental Local Quality Councils and project meetings Provide QA SME Support for manufacturing during out of hours Performs other duties as assigned. Key Metrics * KPI Targets (in addition to abiding relevant quality systems standards (ISO 9001, ISO 13485) & where relevant complying to applicable pharmaceutical GMP standards (US and European) / 21CFR820 as well as abiding & role modelling for all Health, Safety and Environmental rules and guidelines) Deviation assessment completed within 2 days Zero overdue quality records Key Stakeholders * Please specify the stakeholder positions the role will interact with Manufacturing Operations (Cell Banking, Fermentation, Purification and Manufacturing Support) Warehouse and Supply Chain Required Skills & Competencies * (e.g. technical, interpersonal, problem solving) Excellent decision-making and problem solving skills. Strong Quality mindset Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues. Strong Continuous Improvement mindset Excellent communication skills (verbal and written). Ability to meet strict deadlines. Excellent organizational and planning skills. Qualifications (Min. requirements to perform assigned tasks) Education/Degree Field of Study - Scientific Language(s) Required * English 2 - Business Fluent Work Experience Area * Quality (QA or QC) Level * Advanced - 5-10 years

Location: Slough, GB

Posted Date: 6/7/2025