Gmp (good Manufacturing Practices) Product Jobs

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Manufacturing Associate II, Drug Product Operations - Night Shift

Randstad Corporate Services Norwood, MA

Norwood, MA

Today

$35 - $37/hr Full time Aseptic Manufacturing Facilities Management Gmp (good Manufacturing Practices)

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Job Description

Work in a night shift cleanroom environment supporting cGMP drug product manufacturing at an 100% onsite facility in Norwood, MA. This Manufacturing Associate II role focuses on executing and documenting critical sterile drug product operations, including hands-on manufacturing work and detailed batch record review.

Schedule: 6 PM to 6 AM (12-hour shifts), with coverage that may include weekends, holidays, and overtime as needed. The work environment is smoke-free, alcohol-free, and drug-free.

Pay: $35.00 to $37.00 per hour, plus a 25% shift differential.

What you’ll do

Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection in accordance with SOPs and cGMP requirements.
Execute component preparation steps such as washing, sterilization, staging, and transferring components and equipment.
Complete equipment checks, line clearances, material staging, in-process checks, and routine cleaning activities.
Maintain accurate and contemporaneous documentation in MES/eBR, logbooks, and other GMP systems.
Review batch records to find and resolve documentation errors or discrepancies prior to Quality review.
Monitor equipment and process alarms, escalate issues, and document required impact assessments.
Identify and escalate deviations, equipment issues, and process concerns; support troubleshooting and root-cause investigations.
Support material readiness, inventory activities, material transfers, and applicable SAP transactions.
Maintain required cGMP, aseptic, safety, gowning, training, and qualification standards.
Support peer training and continuous improvement initiatives.
Collaborate with cross-functional teams and provide reliable coverage for assigned 12-hour shifts.

What you bring

High School Diploma / GED
2+ years in cGMP manufacturing, pharmaceutical operations, or a related regulated environment (preferred)
Preferred experience in aseptic manufacturing and one or more of: component preparation, formulation, filling, visual inspection, or similar manufacturing operations
Strong attention to detail, including the ability to follow SOPs and complete GMP documentation and batch record reviews
Basic computer skills; familiarity with MES/eBR and SAP or similar manufacturing software systems (preferred)
Ability to work in classified cleanroom environments while following strict gowning and aseptic practices
Ability to work assigned 12-hour shifts, including nights, weekends, holidays, and overtime as required

Tools and systems

MES/eBR
SAP
eBR
Logbooks

Benefits

Medical insurance
Prescription insurance
Dental insurance
Vision insurance
AD&D insurance
Life insurance offerings
Short-term disability
401K plan (eligibility-based)

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