Title: Deviation Management Specialist
Location: Durham, NC 27712
Duration: 12 Months

Qualifications

• B.S./M.S. degree in an appropriate Engineering or Scientific field.

• 0–3 years of post-Bachelor's experience in a cGMP environment (Production, Development, Process Engineering, Technical Services, or a related field) within the pharmaceutical/biotech industry.

• Experience writing investigations for atypical events in a manufacturing environment.

• Familiarity with Lean Six Sigma methodologies and strong analytical/problem-solving skills.

• Ability to work independently and collaboratively in a cross-functional team environment.

• Excellent written and verbal communication skills.

• Ideal candidate will have internship/co-op experience along with 1–2 years of industry experience.

• Experience with manufacturing deviations/incidents and willingness to train on and conduct manufacturing investigations.

Responsibilities

• Provide day-to-day technical support to manufacturing operations.

• Resolve and reduce process deviations through effective investigation and corrective actions.

• Develop and implement Corrective and Preventive Actions (CAPA).

• Lead manufacturing investigations and document findings.

• Provide scientific and technical support for manufacturing areas within Merck's Manufacturing Division (MMD).

• Build strong working relationships with teams supporting aseptic manufacturing, testing, planning, and product release.

• Apply scientific and engineering principles to investigate process deviations.

• Perform troubleshooting and root cause analysis for manufacturing atypical events.

• Analyze complex problems using critical thinking and sound technical judgment.

• Support off-shift activities as required.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $41.00/hr.