{"id":3407214,"url":"https://alion.io/job/pci-pharma-services-qa-officer","title":"QA Officer","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":12,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Operations","role_family":"Operations","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tredegar, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":32000,"max_usd":72000,"period":"year","method":"role_country_seniority_unknown","sample_n":550},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"GDPR","optional":true}],"status":"live","first_seen_at":"2026-10-28T16:36:53Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-01T21:26:24Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\nMain purpose of role:\nQuality Accountability and Responsibility for Production Oversight & Approval, Error Identification and decision making on suitability continue an operation\nOversight of Operations including Manufacturing, Primary and Secondary Packaging and Clinical labelling \nIdentify any potential risk to Quality during routine oversight \nAbility to stop an operation due to quality risk identified \nAbility to investigate and provide resolution to an identified issue \nAbility to approve the re-starting of the line \nTo assist the Quality Management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with the current Good Manufacturing Practise standards in accordance with company policies to meet business requirements. \nTo work with primarily, the Manufacturing, Packaging and Logistics departments to provide QA guidance and expertise in the resolution of quality issues. \nTo ensure the timely release of product by the review of the critical process parameters of the batch documentation to assess the quality, safety and efficacy of the products prior to Qualified Person certification, in accordance with agreed schedules and Service Level Agreements. \nTo perform process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes. \nThe job holder is responsible for the interpretation of GMPs for all manufacturing and packaging areas, including development and distribution stages with support from the Head of Quality and site QP’s. \nThe scope of the Quality Officer role covers all manufacturing and packaging areas across site. (*subject to entry and working practises and related SOPs). \n Main responsibilities\nTechnical/Quality Assurance\nLevel 2\nFully trained in all aspects of Quality Officer (Operational) Level 1 \nBe fully competent to train others in batch documentation review of critical process parameters of the Manufacturing, Clinical and Packaging batches. \nTo provide KPI’s for batch review and manage priorities/workload to ensure that batches are received and released in a timely manner to meet schedules, service level agreements and customer expectations. \nTo perform start up checks, Line Clearance and In Process Checks in line with the production schedule. \nApproval and inspection of Labels. \nMaterial checks prior to batch compilation. \nSupport and drive online triage process. Support Production to ensure that all containment actions are completed. \nMaintain the company pest control programme. \nSupport GEMBA and LEAN activities within Production areas. \nTo perform Site Wide self-inspections and promote continuous improvement across all disciplines \nContinuous Improvement\nReview and improve departmental processes to strengthen key controls and eliminate waste. \nGeneral/Other Duties\nEnsure compliance to cGMP and SOPs throughout the company. \nTo drive and champion best practise for GMP processes - setting examples of high standards of gowning and personal hygiene. \nTo undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job holder’s capabilities and responsibilities \nWork experience & Skills required\nEssential\nKnowledge:\nWorking knowledge of cGMP standards employed at PCI. E.g. EU and US GMP for both drug products and medical devices.\nExperience:\nExperience of working in an Operational Quality environment.\nSkills and Aptitudes:\nHigh standard of written, listening and verbal communication skills. Basic to intermediate competence level in;\nMicrosoft Excel \nMicrosoft Word \nHigh attention to detail.\nThis role is on a 3 shift pattern - Days - Nights - Afternoons\nPersonal Qualities and Behaviours:\nCustomer focussed, Conscientious, Self-motivated, able to lead by example, an ability to get results through co-operation and influence.\nQualifications \nEssential\nMinimum of 5 GCSE’s including English, Maths and preferably a science subject or equivalent pharma industry experience. \nDesirable\nThe job holder will be ideally working towards higher education. E.g. BTEC, Degree or similar. \nRegulatory/Industry Responsibilities\nGeneral\nThe job holder is responsible for adhering to PCI Standard Operating Procedures (SOPs), Health, Safety and Environmental Rules, General Data Protection Regulations (GDPR), Good Manufacturing Practices (GMP) and other regulatory guidelines. \nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. 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