Atrium
Manufacturing Technical Operations Technician (2nd Shift)
Atrium, Boston, Massachusetts, us, 02298
Manufacturing Technical Operations Technician (2nd Shift)
Join Atrium as a Manufacturing Technical Operations Technician on the second shift, responsible for quality records, investigations, and operational compliance at our Boston site.
Base pay range
$55.00/hr – $65.00/hr
This senior‑level role includes complete ownership of quality records such as Deviations, CAPAs, Change Controls, Risk Assessments, and Quality Control Investigations. Responsibilities also cover triage, investigation, root‑cause analysis, driving cross‑functional meetings, promoting compliance best practices, and ensuring timely and thorough completion across the organization.
Key Responsibilities
Triage manufacturing issues in real time on the manufacturing floor.
Use root cause analysis tools to lead and write investigations of quality events in the cell manufacturing, quality control, material operations, and facility operations functional areas.
Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments.
Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
Own, drive, and manage CMC CAPAs and change controls from initiation through closure.
Own deviations, CAPAs, Effectiveness Checks (EC), and Risk Assessment records in the electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
Promote MTO and QA‑aligned compliance best practices to further establish operational and quality event record centre of excellence teams.
Other duties and projects as assigned to meet departmental requirements and clinical timelines.
Qualifications
6+ years progressive experience in pharmaceutical development and manufacturing.
BS in engineering, science, or related discipline.
Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs.
Experienced with technical writing and performing event investigations in a GMP‑compliant environment.
Experience gowning manufacturing floor in Grade B environments.
Contract Length 12 month with the chance to extend
Shift / Hours Sunday‑Thursday, 12 – 8:30 pm, Monday‑Friday 12–8:30 pm and Tuesday‑Saturday 12‑8:30 pm
No C2C or Third‑Party Vendors
Seniority level Associate
Employment type Contract
Job function Manufacturing
Industries Pharmaceutical Manufacturing
This is a temporary role with a third‑party agency partner on assignment at Vertex Pharmaceuticals. The selected individual will be offered employment through the agency partner, with compensation and benefits presented upon offer. The role is eligible for overtime pay in accordance with federal and state requirements.
By applying for this position, you agree to Atrium Terms and Conditions, and Atrium may share your application with Vertex.
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Base pay range
$55.00/hr – $65.00/hr
This senior‑level role includes complete ownership of quality records such as Deviations, CAPAs, Change Controls, Risk Assessments, and Quality Control Investigations. Responsibilities also cover triage, investigation, root‑cause analysis, driving cross‑functional meetings, promoting compliance best practices, and ensuring timely and thorough completion across the organization.
Key Responsibilities
Triage manufacturing issues in real time on the manufacturing floor.
Use root cause analysis tools to lead and write investigations of quality events in the cell manufacturing, quality control, material operations, and facility operations functional areas.
Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments.
Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
Own, drive, and manage CMC CAPAs and change controls from initiation through closure.
Own deviations, CAPAs, Effectiveness Checks (EC), and Risk Assessment records in the electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
Promote MTO and QA‑aligned compliance best practices to further establish operational and quality event record centre of excellence teams.
Other duties and projects as assigned to meet departmental requirements and clinical timelines.
Qualifications
6+ years progressive experience in pharmaceutical development and manufacturing.
BS in engineering, science, or related discipline.
Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs.
Experienced with technical writing and performing event investigations in a GMP‑compliant environment.
Experience gowning manufacturing floor in Grade B environments.
Contract Length 12 month with the chance to extend
Shift / Hours Sunday‑Thursday, 12 – 8:30 pm, Monday‑Friday 12–8:30 pm and Tuesday‑Saturday 12‑8:30 pm
No C2C or Third‑Party Vendors
Seniority level Associate
Employment type Contract
Job function Manufacturing
Industries Pharmaceutical Manufacturing
This is a temporary role with a third‑party agency partner on assignment at Vertex Pharmaceuticals. The selected individual will be offered employment through the agency partner, with compensation and benefits presented upon offer. The role is eligible for overtime pay in accordance with federal and state requirements.
By applying for this position, you agree to Atrium Terms and Conditions, and Atrium may share your application with Vertex.
#J-18808-Ljbffr