Manufacturing Assoc, Drug Product Ops - Nights

Manufacturing Associate II, Drug Product Operations - Night Shift - 6pm-6am

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 25% shift differential)

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.

INTERESTED, APPLY NOW! THESE ROLES FILL QUICKLY!

salary: $35 - $37 per hour
shift: First
work hours: 6 PM - 6 AM
education: High School

Responsibilities

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 escalate deviations, equipment issues, and process concerns; support troubleshooting and root-cause investigations.

Equipment & Alarm Management:

• Monitor equipment and process alarms, escalate issues, and document required impact assessments.

Materials & Systems:

• 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).

The essential functions of this role include:

• working weekends

Skills

• cGMP
• GMP
• Pharmaceutical Manufacturing

Qualifications

• Years of experience: 2 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.