Manufacturing Senior Associate-NS

Spectraforce Technologies; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Spectraforce Technologies in Holly Springs, NC is seeking a Manufacturing Specialist Investigator to own major and trend deviations, identifying root causes and contributing to CAPA design. This role collaborates with manufacturing leads, engineering, quality, and supply chain to minimize product impact and drive process improvement.

You will lead root cause analysis using tools like fishbone, 5 Whys, FMEAs, and fault tree analysis, prepare technical reports with data analysis, and communicate

Qualifications

• Own major and trend deviations to support root cause and CAPAs.
• Interact with Manufacturing leads, Engineering, Quality, Supply Chain to mitigate product impact.
• Lead root cause analyses using fishbone diagrams, 5 Whys, FMEAs, and fault tree.
• Prepare final technical reports with data collection and analysis.
• Communicate investigation progress and risks to management.

Responsibilities

• Lead root cause analysis to identify failure modes.
• Collaborate with cross-functional teams to mitigate product impact.
• Identify correct actions to prevent recurrence.
• Perform trend investigations and statistical assessments.
• Generate final technical reports.
• Alert senior management to quality, compliance, safety risks.
• Drive improvement projects and CAPAs.

Skills

Follow instructions SOPs

Shift adherence

Learning agility

Strong technical writing

Education

Doctorate degree

Masters degree with 3 years Manufacturing

Bachelors degree with 5 years Manufacturing

Associates degree with 10 years Manufacturing

High school diploma/GED + 12 years Manufacturing/Operations

Job description

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.