Manufacturing Associate

tsu.edu; Norwood (MA); In loco; USD 100.289.000 - 108.886.000; Tempo pieno

Descrizione del lavoro

tsu.edu in Norwood, MA is seeking a Manufacturing Associate II for Drug Product Operations. You will execute cGMP manufacturing activities, including preparation, sterilization, aseptic filling, and visual inspection, ensuring compliant documentation and reliable operations.

This 6+ month contract requires night shifts (6 PM–6 AM) with weekend coverage and collaboration across functions to support material readiness, batch records, and SAP/MES workflow.

Competenze

• 2+ years of experience in cGMP manufacturing or related regulated environment.
• Experience with aseptic manufacturing and visual inspection.
• Ability to work 12-hour shifts, including nights, weekends, and overtime as needed.

Mansioni

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection per SOPs and cGMP.
• Complete equipment checks, line clearances, material staging, and in-process checks.
• Monitor alarms, document impact assessments, and perform batch record review.
• Maintain GMP documentation and support cross-functional teams.
• Support material readiness, inventory, SAP transactions, and deviations handling.
• Provide coverage for 12-hour shifts, including weekends and holidays.

Conoscenze

cGMP manufacturing

Aseptic processing

SOP adherence

Batch record review

MES/eBR familiarity

SAP experience

Teamwork and communication

Formazione

High school diploma or GED

Associate's or Bachelor's degree in a scientific or technical field preferred

Strumenti

MES/eBR

SAP

Descrizione del lavoro

Title: Drug Product Operations Manufacturing Associate
Location: Norwood, MA
Pay: $35-38/hr
Contract: 6+ months

Shift: NIGHTS (Sun-Wed) 6PM-6AM OR NIGHTS (WED-SAT) 6PM-6AM

Job Summary

The Manufacturing Associate II, Drug Product Operations is responsible for executing cGMP manufacturing activities, including component preparation, sterilization, material wiping and transfer, formulation, filtration, aseptic filling, and visual inspection. The role supports equipment and material readiness, performs in-process checks, monitors and responds to alarms, documents impact assessments, and performs batch record review. The associate ensures accurate GMP documentation and works collaboratively across functions to maintain safe, compliant, and reliable manufacturing operations.

Job Responsibilities

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection in accordance with SOPs and cGMP requirements.
• Perform component preparation activities, including washing, sterilization, staging, and transfer of components and equipment.
• Complete equipment checks, line clearances, material staging, in-process checks, and routine cleaning activities.
• Monitor equipment and process alarms, escalation issues, and document required impact assessments.
• Complete accurate and contemporaneous documentation in MES/eBR, logbooks, and other GMP systems.
• Perform batch record review to identify and resolve documentation errors or discrepancies prior to Quality review.
• Support material readiness, inventory activities, material transfers, and applicable SAP transactions.
• Identify and elevate deviations, equipment issues, and process concerns; support troubleshooting and investigations.
• Maintain required cGMP, aseptic, safety, gowning, training, and qualification requirements; support peer training and continuous improvement.
• Collaborate with cross-functional teams and provide reliable coverage for assigned 12-hour shifts, including weekends, holidays, and overtime as needed.

Education & Qualifications

• High school diploma/GED required; Associate’s or Bachelor’s degree in a scientific or technical field preferred.
• 2+ years of experience in cGMP manufacturing, pharmaceutical operations, or a related regulated environment preferred.
• Experience with aseptic manufacturing, component preparation, formulation, filling, visual inspection, or similar manufacturing operations preferred.
• Strong attention to detail with demonstrated ability to follow SOPs, execute GMP documentation, and perform batch record review.
• Ability to work effectively in classified cleanroom environments, including required gowning and aseptic practices.
• Strong communication, teamwork, reliability, and ability to identify and elevate process, equipment, or alarm-related issues.
• Basic computer skills and familiarity with MES/eBR, SAP, or other manufacturing systems preferred.
• Ability to work assigned 12-hour shifts, including nights, weekends, holidays, and overtime as required.