At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job FunctionQualityJob Sub FunctionQuality ControlJob CategoryProfessionalAll Job Posting Locations:Ringaskiddy, Cork, IrelandJob DescriptionPOSITION SUMMARYThe candidate must have a strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry or Microbiology. The candidate must have prior supervisory experience of working in an IMB/FDA regulated facility.The Individual Will Be Responsible ForQualification of analytical equipment and related testing functions such as HPLC, Spectrophotometry, Nephelometry and Total Organic Carbon etc.Sampling and testing coordination during plant and laboratory utility qualification.Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs.Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.Implementation of Analyst Training programs. Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient mannerGeneral Scope Of ResponsibilitiesSupports Team leader on day to day testing operations.Performs Data and QC Investigations review and approval.Reviews Specifications and plans for associated LIMS scheduling.Reviews and approves deviations, CAPA's and Change Control.Plans and oversees lab related projects, ie., Method transfers, Equipment Qualification etc.Proactively identifies and drives lab process improvements.Trains laboratory team on specific analytical technology.Provides subject matter expert technical support on specific analytical technology.Supports lean initiatives in the area of lab operations, ie., test method execution, documentation updates and equipment qualification etc.Presents technical analytical clearly and concisely data to customers, internal investigations and regulatory inspectors, etc.Keeps abreast of analytical technology and compliance trends.Key Competencies RequiredCollaboration and team workStrategic thinkerProblem solving and attention to detailResults and performance drivenCoaching and mentoring styleIntegrity, trustworthiness and objectivityCustomer focusClear communication skillsAdaptable and flexibleInnovativeInclusive, facilitative styleKEY INDIVIDUAL CONTRIBUTOR COMPETENCIESBuilds strong productive relationshipsDemonstrates ability to work with teams and individualsAsserts personal ideas and opinions using persuasion to influence othersSeeks opportunities to grow and develop professionallyUses best practices to improve business operationsHolds self accountable for compliant and flawless executionTakes personal responsibility for decisions that successfully build customer valueEffectively manages and adapts to changeDemonstrates the courage to stand alone on ideas and opinions that differ from othersListens effectively and remains open to other's ideasWorks effectively with people that have diverse styles, talents and ideasQualifications And ExperienceBachelor's Degree in Chemistry or related field4-6 years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experienceWorking knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processesWorking knowledge of Quality systemsStrong technical knowledge in and experience with QC analytical testing methods and equipment is requiredKnowledge of cGMP regulations and FDA/EU guidance is requiredEssentialSupport cGMP routine testing by owning quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) resultsEnsure effective planning of the data review assignments by completing data validation within data review windowPerform data review assignments in accordance with the established laboratory procedures on data integrity and documentationDrive, author, and review laboratory documents, such as protocols, reports, standard operating procedure, work instructions and other quality documents as per requirementOperate and provide support for overall laboratory instruments/equipment as per requirementLead and provide training to colleagues as SMEInitiate change requests with applicable procedures /policiesEscalate any non-conformances noted immediately to the supervisor/ in-charge, initiate Quality Issues identified as per applicable procedure, participate in the investigation, perform investigation analysis, and provide necessary information to enable implementation of effective CAPAProvide strong technical/scientific support to internal and external customers when needed.Develop qualification or validation methods to be used by the Quality Control unitParticipate and lead in special projects as QC analytical technical team memberEnsure effective capacity planning and performance management of the task assigned.Required SkillsPreferred Skills:Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy