Job Title:

Manufacturing Specialist Investigator Location:

Holly Springs, NC Duration:

12 Months (Possibility of extension depending upon business requirements and performance)

Shift:

Rotating 2-2-3 (5:45PM - 6:15AM) 12 hour shift Top 3

Must Have Skill Sets:

Ability to follow instructions and SOP's. Able to work assigned shift. Learning agility.

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. What we expect of you We 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 OR Masters 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 Possible Extension:

Yes Red Flags:

If they do not have any experience in a regulated industry such as the food industry.