Manufacturing Associate II

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.

location: Norwood, Massachusetts
job type: Contract
salary: $36.75 - 38.85 per hour
work hours: 3 to 11
education: High School

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, escalate 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 escalate 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.

 
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 escalate 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.

#LI-AH1

skills: SOP Development, Good Manufacturing Practices (GMP), Aseptic Processing


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.