Job Title: Associate Principal QA Specialist 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 1. Job Details Supervisory Organization* QA Technical Operations Reports to position* QA Manager (QA Technical Support) Job Title* Associate Principal QA Specialist, QA Technical Operations Job Profile N/A Primary Location* Slough Additional Location(s) None 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* (define specific short & long-term work duties starting with the most frequent and impactful) · 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* Organization Size ( of direct/indirect reports) Financial responsibility (e.g. budget, Revenue) 0 None 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. 2. Qualifications (Min. requirements to perform assigned tasks) Education/Degree Required* Scientific Field of Study Scientific Preferred N/A Field of Study N/A Language(s) Required* English Ability Level 2 - Business Fluent Preferred N/A Ability Level Choose an item. Certifications (incl. professional qualifications) i.e. ACCA, GPHR, CIPS, PgMP Required N/A Issuer N/A Preferred N/A Issuer N/A Work Experience (If UK location - NO years of experience should be included) Area* Quality (QA or QC) Level* Advanced - 5-10 years Area N/A Level Choose an item. Other Requirements · None Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy