Manufacturing Investigation Specialist
Job Description
ROLE: Manufacturing Investigations Staff (2nd Shift)
\n
LENGTH: 12+ Months
\n
LOCATION: ONSITE in Boston, MA
\n
SHIFT: 2nd Shift
\n
\n
Responsibilities:
\n
• Lead/Own and execute quality records including Deviations, CAPAs, Change Controls, and QC/Analytical Investigations supporting pharmaceuticals manufacturing.
\n
• Lead deviation triage, investigation planning, event initiation, and initial impact assessments.
\n
• Conduct investigations across Manufacturing, QC, Materials, Facilities, and Equipment operations.
\n
• Perform SME interviews, GEMBA activities, data review, and root cause analysis.
\n
• Lead and document root cause investigations and recommend appropriate corrective and preventive actions.
\n
• Own CAPAs and Change Controls from initiation through execution and closure.
\n
\n
Required:
\n
• 5+ years of engineering, project management, pharmaceutical, or related industry experience for senior-level candidates.
\n
• Strong experience with quality event management, deviations, CAPA, Change Controls, and investigations.
\n
• Experience performing root cause analysis and developing corrective/preventive actions.
\n
• Experience working in pharmaceutical/biopharmaceutical manufacturing or a regulated GMP environment.
\n
\n
\n
Target Pay Rate: $50–$65/HR
\n
Final rate within this range will be based on skills, experience, and interview results.