Deviation Management Specialist (Biotech)

TL;DR

Deviation Management Specialist (Biotech): Providing technical support to manufacturing operations by resolving process deviations and leading investigations with an accent on cGMP compliance and root cause analysis. Focus on developing corrective and preventative actions to ensure quality standards in a pharmaceutical manufacturing environment.

Location: Must be based in Durham, NC

Salary: $80,400–$86,900

hirify.global is a staffing agency providing professional placement services across various technical and scientific industries.

What you will do

• Provide day-to-day technical support to manufacturing operations.
• Lead manufacturing investigations into atypical events.
• Develop and implement corrective and preventative actions (CAPA).
• Utilize scientific and engineering principles to resolve process deviations.
• Collaborate with cross-functional teams in aseptic manufacturing, testing, and planning.
• Perform root cause analysis on complex manufacturing issues.

Requirements

• B.S. or M.S. degree in an engineering or scientific field.
• 0-3 years of experience in a cGMP environment within the pharmaceutical or biotech industry.
• Experience writing investigations for atypical events in manufacturing.
• Familiarity with Lean Six Sigma methodologies.
• Strong analytical and problem-solving capabilities.
• Ability to work independently and within a cross-functional team.

Culture & Benefits

• Major medical, dental, and vision insurance for assignments lasting 13+ weeks.
• 401k retirement plan participation.
• Statutory sick pay where required by law.
• Commitment to reasonable accommodations for individuals with disabilities.
• Participation in E-Verify program.