Manufacturing Senior Associate-NS

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.

• 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.

• 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

• 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

• High school/GED + 2 years work experience

OR

• Associates and 6 months work experience

OR

• Bachelors

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