Manufacturing Associate

Randstad USA; Norwood (MA); On-site; USD 73,000 - 77,000; Full time

Benefits offered by this job

Shift differential

Job summary

Randstad USA is seeking a Manufacturing Associate II for Drug Product Operations in Norwood, MA. The role involves cGMP manufacturing activities including preparation, sterilization, aseptic filling, and visual inspection, with a strong emphasis on documentation and cross-functional collaboration.

Responsibilities include equipment readiness, in-process checks, alarm monitoring, batch record reviews, and compliance with cGMP standards.

Qualifications

• High School diploma or GED required.
• Associate’s or Bachelor’s degree preferred in scientific/technical field.
• 2+ years of cGMP/pharma manufacturing experience preferred.

Responsibilities

• Prepare components, sterilize, formulate, fill and inspect aseptically.
• Monitor equipment readiness and alarms; assist with line clearances and material staging.
• Document GMP/ MES/eBR entries and perform batch record reviews.

Skills

Cleanroom

Communication

Teamwork

Reliability

Education

High School Diploma/GED

Associate/Bachelor preferred

Tools

MES/eBR

SAP

Job description

Manufacturing Associate II, Drug Product Operations

Role Overview

The Manufacturing Associate II, Drug Product Operations executes cGMP manufacturing activities, including component preparation, sterilization, material wiping and transfer, formulation, filtration, aseptic filling, and visual inspection.

This role supports equipment and material readiness, performs in-process checks, monitors and responds to alarms, documents impact assessments, and conducts batch record reviews. The Associate ensures accurate GMP documentation and collaborates cross‑functionally to maintain safe, compliant, and reliable manufacturing operations.

Pay:

$35.00-37.00 per hour (plus 5% shift differential)

Key Responsibilities

Core Operations:

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection in accordance with SOPs and cGMP requirements.
• Execute 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.

Quality & Documentation:

• Complete accurate and contemporaneous documentation in MES/eBR, logbooks, and other GMP systems.
• Perform batch record reviews to identify and resolve documentation errors or discrepancies prior to Quality review.
• Identify and elevate deviations, equipment issues, and process concerns; support troubleshooting and root-cause investigations.

Equipment & Alarm Management:

• Monitor equipment and process alarms, elevate issues, and document required impact assessments.
• Support material readiness, inventory activities, material transfers, and applicable SAP transactions.

Compliance & Continuous Improvement:

• 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 (including weekends, holidays, and overtime as needed).

Qualifications & Experience

Education

• Required: High School Diploma / GED
• Preferred: Associate's or Bachelor's degree in a scientific or technical field

Experience & Technical Skills

• Experience: 2+ years in cGMP manufacturing, pharmaceutical operations, or a related regulated environment (preferred).
• Technical Background: Experience with aseptic manufacturing, component preparation, formulation, filling, visual inspection, or similar manufacturing operations (preferred).
• Compliance & Quality: Strong attention to detail with demonstrated ability to follow SOPs, execute GMP documentation, and perform batch record reviews.
• Systems: Basic computer skills and familiarity with MES/eBR, SAP, or other manufacturing software systems (preferred).

Core Competencies & Workplace Expectations

• Ability to work effectively in classified cleanroom environments, adhering to strict gowning and aseptic practices.
• Strong communication, teamwork, and reliability with a proactive approach to identifying and escalating process, equipment, or alarm issues.
• Capability to work assigned 12‑hour shifts, including nights, weekends, holidays, and overtime as required.

Working Model & Company Environment

• Onsite Expectation: 100% Onsite. Being physically present is critical to site-based operations, real-time collaboration, strong team connections, direct mentorship, and hands‑on partnership.
• Workplace Culture: This is a smoke‑free, alcohol‑free, and drug‑free work environment.