New 
Manufacturing Senior Associate-NS
 Spectraforce Technologies | |
 United States, North Carolina, Holly Springs | |
 Aug 06, 2026 | |
| 100% Onsite - Holly Springs NC (USNC) SitePlease source at open market rateShift: Rotating 2-2-3 (5:45PM - 6:15AM) 12 hour shift Manufacturing Specialist InvestigatorJob Description:The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional conceptualization of design solutions (CAPAs). Maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and supply to product/process improvement.? Lead root cause analysis to identify the failure mode.? Identify root cause using tools such as fishbone diagrams, ?5 Whys?, KT, Process mapping, and risk assessments such as FMEA?s or Fault Tree Analysis.? Applies knowledge and subject matter expertise to ensure end-to-end of investigations? Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis.? Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports.? Generate final technical reports, which may include data collection and statistical analysis of the data? Perform notification of potential product impact.? Advise management on investigation progress, product/ process risk, and potential delays.? Support functional management initiatives and objectives? Anticipates and prevents potential issues with regulators? Own and/or Drive Improvement projects/initiatives? Collaborate cross functionally as needed to ensure the Quality Management System processes are completed in accordance with established procedures.? Alert senior management of quality, compliance, supply and safety risks. What we expect of youWe are all different, yet we all use our unique contributions to serve patients.The Manufacturing Specialist Investigator we seek is an excellent communicator with these qualifications:Doctorate degree ORMaster?s degree and 3 years of Manufacturing orOperations experience OrBachelor?s degree and 5 years of Manufacturing orOperations experienceOrAssociate?s degree and 10 years of Manufacturing orOperations experienceOrHigh school diploma / GED and 12 years of Manufacturing or Operations experiencePreferred Qualifications:5+ years of proven ability in investigation process.Strong technical writingProven Six Sigma proficiency specifically for root cause analysis methodologyUnderstanding and application of Drug Substance process, data mining, quality and compliance.Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiativesProject Management experienceAble to influence tri-functional team and interpersonal leads Enable Skills-Based Hiring No Basic Qualifications High school/GED + 2 years work experience OR? Associate?s and 6 months work experience OR? Bachelor?sMax Rate Not to Exceed (If this differs from the job posting template): (No Value)Why is the Position Open? Supplement additional workload on teamTop 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) {} Ability to follow instructions and SOP's.Able to work assigned shift.Learning agility.Day 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) {} See job description.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) {} Amgen experiencePossible 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) {} If they do not have any experience in a regulated industry such as the food industry.Interview 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) {} 2 Stages of interviews | Virtual | |