Amgen Thousand Oaks Onsite onlyoDuring Business Hours 8:00-5:00 PM, email, work, We are seeking a highly motivated and detail oriented individual with strong expertise in life sciences and Laboratory Information Management Systems (LIMS) to support the modernization of our global Bioanalytical Sciences LIMS/ELN ecosystem. This group performs assays for small molecule and peptide analysis using LC-MS/MS, ELISA assays using MSD and Spectrmax readers and Immunogenicity assays that are Anti-drug antibody and Neutralizing Antibody assays using MSD, Spectramax, Envision and Vicell type readers. This contract offers the opportunity to contribute to a major digital transformation initiative within a world class scientific organization.You will work closely with the global Pharmacokinetics and Drug Metabolism – Bioanalytical Sciences (PKDM BA) team, collaborating with colleagues across sites in California and Germany, as well as with software vendors and internal subject matter experts. Your work will directly shape the implementation of our new LabVantage LIMS/ELN platform and help harmonize data and workflows across our global bioanalytical community.Key ResponsibilitiesFor Controlled Environment Equipment (CEE) which includes freezers, refrigerators, desiccators and Liquid Nitrogen tank), the role would be responsible for the following items:Inventory Manager to build inventory from each type of controlled chambers (e.g., refrigerator, freezer, LN2, Ambient, etc.)Build a process with BA lab staff of check-in and checkout of these controlled chambers.Tracks products in low temperature, focusing on accuracy, safety, and efficiency by managing receiving, storing, picking, and shipping, conducting cycle counts, resolving discrepancies (like damages/shorts), and generating reports, all while upholding strict health/safety/regulatory standards like FDA. BA Operations Oversight: Manage daily inventory flow, including receiving, put-away, picking, packing, and dispatching of goods.Inventory Accuracy: Conduct regular cycle counts and full physical inventories; reconcile physical stock with system records.Discrepancy Resolution: Investigate and resolve issues like damaged goods, short shipments, missing items, and customer claims.System Management: Process adjustments, updating records, and generating reports on inventory levels, movement, and performance.Cold Chain Compliance: Monitor and maintain temperature/humidity controls and enforce proper handling to preserve product integrity.Safety & Security: Enforce company safety policies, monitor security protocols, and ensure compliance with FDA guidelines.Reporting & Analysis: Generate inventory reports and analyze trends to support and process improvements.Coordination: Liaise BA lab staff and management to ensure smooth workflow. Master Data IntegrationLead the integration of assay and study metadata, reagent and equipment information, and experimental raw data/results from multiple legacy systems into a unified global LIMS environment.Builds inventory from each type of controlled chamber (e.g., refrigerator, freezer, LN2, Ambient, etc.) into an inventory management system.Testing & ComplianceContribute to test planning and execution to ensure the LIMS/ELN solution meets specifications, supports bioanalytical workflows, and complies with Amgen standards and regulatory requirements (including GxP and FDA 21 CFR Part 11).DocumentationCreate and maintain clear, comprehensive documentation covering requirements, processes, data flows, configurations, and user guides.Training & User SupportAssist in developing and delivering training to end users adopting the new LIMS/ELN system.Collaboration & CommunicationServe as a liaison between PKDM-BA labs (ATO and ASF), research teams, technology teams, and software vendors.Foster strong collaboration across diverse groups including bench scientists, data scientists, software engineers, and data engineers.Qualifications & SkillsEducation & ExperienceBachelors in life sciences, computer sciences, or a related fieldMinimum 2 years of direct experience working with laboratory software and electronic data processes in the pharma/biotech industry.Experience in inventory roles, preferably in cold storage or logistics.Regulatory & Quality KnowledgeExperience with Laboratory Information Management Systems and Electronica Laboratory Notebooks (e.g., Watson LIMS, StarLIMS, IDBS ELN, Others) would be helpful. Experience in GxP environments and understanding of computerized system validation and regulatory frameworks (e.g., FDA 21 CFR Part 58 and part 11) is desired.Soft Skills & Ways of WorkingSelf-driven and consistent demonstration of initiativeAbility to multi-task activities while maintaining attention to detailsExcellent communication skillsStrong analytical, organizational, and problem solving abilities.Demonstrated success collaborating with cross functional scientific and technical teams.Adaptability, energy, and willingness to work across time zones.Innovative mindset with a track record of driving ideas to implementation.Ability to work effectively in a cross-functional, team matrix environmentComfortable interacting with a diverse team with wide-ranging skillsets.Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio and OutlookKnowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommendedIf you’re passionate about enabling cutting edge science through modern informatics solutions and thrive in a collaborative, fast paced environment, we’d love to hear from you. Enable Skills-Based Hiring No Basic Qualifications Masters degree OR Bachelors degree and 2 years of experience OR Associate’s degree and 4 years of experience OR High school diploma / GED and 6 years of experienceMax Rate Not to Exceed (If this differs from the job posting template): (No Value)Why is the Position Open? .Top 3 Must Have Skill Sets:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113070677850528909'), text: "What\x20skills\x20must\x20be\x20on\x20a\x20resume\x20in\x20order\x20to\x20move\x20them\x20to\x20the\x20interview\x20stage\x3F"}).initialize();} catch(err) {} ducation & Experience Bachelors in life sciences, computer sciences, or a related field Minimum 2 years of direct experience working with laboratory software and electronic data processes in the pharma/biotech industry. Experience in inventory roles, preferably in cold storage or logistics.Regulatory & Quality Knowledge Experience with Laboratory Information Management Systems and Electronica Laboratory Notebooks (e.g., Watson LIMS, StarLIMS, IDBS ELN, Others) would be helpful. Experience in GxP environments and understanding of computerized system validation and regulatory frameworks (e.g., FDA 21 CFR Part 58 and part 11) is desired.Soft Skills & Ways of Working Self-driven and consistent demonstration of initiative Ability to multi-task activities while maintaining attention to details Excellent communication skills Strong analytical, organizational, and problem solving abilities. Demonstrated success collaborating with cross functional scientific and technical teams. Adaptability, energy, and willingness to work across time zones. Innovative mindset with a track record of driving ideas to implementation. Ability to work effectively in a cross-functional, team matrix environment Comfortable interacting with a diverse team with wide-ranging skillsets. Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio and Outlook Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommendedDay to Day Responsibilities:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113075241056150909'), text: "What\x20do\x20you\x20expect\x20this\x20worker\x20to\x20accomplish\x20and\x20how\x20will\x20you\x20determine\x20if\x20this\x20placement\x20was\x20successful\x3F"}).initialize();} catch(err) {} .Key ResponsibilitiesFor Controlled Environment Equipment (CEE) which includes freezers, refrigerators, desiccators and Liquid Nitrogen tank), the role would be responsible for the following items: Inventory Manager to build inventory from each type of controlled chambers (e.g., refrigerator, freezer, LN2, Ambient, etc.) Build a process with BA lab staff of check-in and checkout of these controlled chambers. Tracks products in low temperature, focusing on accuracy, safety, and efficiency by managing receiving, storing, picking, and shipping, conducting cycle counts, resolving discrepancies (like damages/shorts), and generating reports, all while upholding strict health/safety/regulatory standards like FDA. BA Operations Oversight: Manage daily inventory flow, including receiving, put-away, picking, packing, and dispatching of goods. Inventory Accuracy: Conduct regular cycle counts and full physical inventories; reconcile physical stock with system records. Discrepancy Resolution: Investigate and resolve issues like damaged goods, short shipments, missing items, and customer claims. System Management: Process adjustments, updating records, and generating reports on inventory levels, movement, and performance. Cold Chain Compliance: Monitor and maintain temperature/humidity controls and enforce proper handling to preserve product integrity. Safety & Security: Enforce company safety policies, monitor security protocols, and ensure compliance with FDA guidelines. Reporting & Analysis: Generate inventory reports and analyze trends to support and process improvements. Coordination: Liaise BA lab staff and management to ensure smooth workflow.Employee Value Proposition:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113083697469551909'), text: "Why\x20should\x20someone\x20who\x20is\x20a\x20gainfully\x20employed\x20consider\x20leaving\x20their\x20current\x20role\x20for\x20this\x20opportunity\x3F"}).initialize();} catch(err) {} .Possible Extension:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113103954696047909'), text: "Is\x20it\x20likely\x20to\x20get\x20extended\x20past\x20the\x20job\x20posting\x20end\x20date\x3F"}).initialize();} catch(err) {} YesRed Flags:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113113634890332909'), text: "Anything\x20you\x20do\x20not\x20want\x20to\x20see\x20in\x20resumes\x20or\x20that\x20might\x20deter\x20you\x20from\x20scheduling\x20an\x20interview\x3F"}).initialize();} catch(err) {} .Poor interpersonal skills, no lab experienceInterview Process:try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz16041113121951580569909'), text: "How\x20many\x20interviews\x20do\x20you\x20plan\x20to\x20conduct\x3F\x20\x28Phone\x20or\x20In\x2DPerson\x29\x20What\x20is\x20your\x20availability\x20to\x20start\x20interviewing\x3F"}).initialize();} catch(err) {} 1 Phone and 4 in person interviews or virtual interviews
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 7.25/hr.