Job Title

Job Title: QA AssociateJob Type: 9 Month ContractHours of work: Mon – FriIndustry: PharmaceuticalsLocation: Slough, EnglandSalary: £23.08 per hour - PAYEFully on site.Job Details Supervisory OrganizationQA OperationsReports to positionAssociate Director, QAJob TitleQA Associate – QA Operations Batch ReviewJob ProfileGrade 7Primary LocationSloughRole Purpose & ScopeEnable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership.Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and to enable the Lonza Slough Site to deliver to relevant targets. This will be achieved by assessing compliance to site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership.Supporting Senior QA leadership to drive continuous improvement.Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and Lonza’s Customer expectations.Key ResponsibilitiesTo provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.Acting as a point of contact for general queries relating to Quality and escalating as required.Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.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 activitiesMentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.Maintain and promote a state of audit readiness.Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.Required Skills & CompetenciesSkillsIT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entriesVerbal and written communication skillsRisk based decision makingPQS experienceAccurate data entry skills, high attention to detailDemonstrated workload prioritization skills, decision making and scheduling skillsAbility to meet strict deadlinesGood organizational and planning skills.CompetenciesAgilityDemonstrates an ability and desire to learn from experienceTreats errors as a learning opportunityIs willing to take on new challengesTakes steps to adapt thinking and behavior to support changeBusiness AcumenSeeks to understand the corporate strategy and how his/her business area contributes to the company’s successUnderstands the impact of his/her own actions on his/her business areaExpresses ideas that will improve his/her business areaUses knowledge of his/her business area to make accurate and timely decisionsCollaborationWorks as an active member of his/her teamGenerously shares information and knowledge with others on the teamDemonstrates an openness to different perspectives by balancing listening and speakingTreats all co-workers and customers professionally and with respectCustomer FocusUnderstands what internal and/or external customers need from him/her to deliver in his/her respective roleDemonstrates an openness to receiving customer feedbackTakes action to enhance customer satisfaction within the scope of his/her roleDriving ResultsConsistently delivers goals while monitoring KPIs with supervisorDemonstrates persistence and motivation to overcome obstacles and challengesEnsures quality standards are maintained while delivering resultsPlans, prioritises and organises work to deliver on timeLeadershipTakes responsibility for his/her safety and that of othersTakes responsibility for personal choices and behavioursSeeks feedback and reflects on his/her development needs in order to continuously improveContributes to a positive work environmentActs as a reliable and dependable member of the teamQualifications (Min. requirements to perform assigned tasks)Education/DegreeRequiredBachelors of Science (or equivalent experience)Field of StudyBiology or related fieldLanguage(s)RequiredEnglishAbility Level2 - Business FluentWork Experience Area*Previous work experience in QA / GMP experience is useful though not essentialOther RequirementsQuality : Utilising knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel. Obtaining confirmation on any issue of which unsureSafety : Maintaining a safe working environment for self and all employees. Actively identifying potential safety risks and working to mitigate these.