Position: Manufacturing Technical Operations
Location: Boston, MA
Length: 12 Month Contract
 

Job Description
The QE Execution Staff member supports Manufacturing Technical Operations (MTO) through the ownership and execution of quality records supporting cell manufacturing operations. This role manages Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations from initiation through completion.

Responsibilities include data review, interviews, root cause analysis, GEMBA investigations, project management, cross-functional collaboration, and clear communication. The role follows MTO Engineering Operations processes and Quality Assurance-aligned best practices to execute quality records efficiently and effectively.

Essential Duties and Responsibilities

• Participate in deviation triage, investigational planning, coordination, and event initiation.
• Identify and collaborate with subject matter experts during triage and investigations.
• Determine immediate actions and containment measures.
• Document initial impact assessments.
• Lead investigations for manufacturing, Quality Control, materials, facilities, and equipment deviations.
• Conduct interviews and GEMBA activities using appropriate root cause analysis tools.
• Lead and document quality events across cell manufacturing, Quality Control, materials operations, and facilities operations.
• Collaborate with subject matter experts to determine root causes and propose appropriate corrective and preventive actions.
• Own, drive, and manage CMC CAPAs and Change Controls through initiation, assessment, planning, execution, and closure.
• Manage Deviations, CAPAs, Effectiveness Checks, and Change Controls in the electronic Quality Management System (eQMS).
• Ensure quality records meet established timelines and due dates.
• Promote MTO and Quality Assurance-aligned compliance best practices.
• Track deliverables and escalate issues promptly using the designated MTO project management tool.
• Perform other duties and projects as assigned to meet departmental requirements and manufacturing timelines.

Qualifications

• Expert Level: Any degree with 10+ years of experience in engineering, project management, pharmaceutical operations, or a related field. Experience working in a fast-paced environment required.
• Senior Level: Any degree with 5–10 years of experience in engineering, project management, pharmaceutical operations, or a related field. Experience working in a fast-paced environment required.
• Mid-Level: Engineering or relevant degree with 2–5 years of work experience. Some industry experience preferred.
• Junior Level: Engineering degree with 0–1 year of experience. Eagerness to learn about the industry required.
• Experience with investigations, root cause analysis, CAPAs, Change Controls, or related quality processes preferred.
• Strong collaboration, communication, organization, and project management skills.
• Ability to work on-site in Boston and support an assigned shift.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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