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Hours Full-time, Part-time
Location Holly Springs, North Carolina

About this job

Title: Manufacturing Specialist Investigator
Location: Holly Springs NC
Duration: 12 months (Day shift)

Description:

Job 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 FMEAs 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.
The Manufacturing Specialist Investigator we seek is an excellent communicator with these qualifications:
  • Doctorate degree OR Mastes degree and 3 years of Manufacturing or Operations experience Or Bachelors degree and 5 years of Manufacturing or Operations experience or Associates degree and 10 years of Manufacturing or Operations experience Or High school diploma / GED and 12 years of Manufacturing or Operations experience
Preferred Qualifications:
  • 5+ years of proven ability in investigation process.
  • Strong technical writing
  • Proven Six Sigma proficiency specifically for root cause analysis methodology Understanding 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 initiatives
  • Project Management experience
  • Able to influence tri-functional team and interpersonal leads
Basic Qualifications
  • High school/GED + 2 years work experience OR? Associates and 6 months work experience OR Bachelors
Top 3 Must Have Skill Sets:
  • Ability to follow instructions and SOP's.
Possible Extension:
  • Yes
Red Flags:
  • If they do not have any experience in a regulated industry such as the food industry.
Interview Process:
  • Virtual

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Posting ID: 1287035949 Posted: 2026-08-09 Job Title: Manufacture Senior Associate
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Manufacture Senior Associate