Mfg Assoc - Drug Substance Operations
- Bachelor’s degree in a STEM field with 0–1 years of relevant industry experience OR
- Associate’s degree with 2–4 years of relevant industry experience OR
- High School Diploma with 4+ years of relevant industry experience.
- Experience in manufacturing, operations, biopharma, life sciences, or other regulated/technical environments is helpful.
- Interest in a structured, digital-forward advanced biomanufacturing environment.
- Comfort working in a cleanroom environment, wearing required gowning, and closely following defined procedures.
- Solid attention to detail with a disciplined, consistent approach to execution.
- Excellent focus, accountability, team-first mindset, and professional judgment.
- Confidence to speak up early, escalate issues appropriately, and foster a culture of quality and continuous improvement.
shift: First
work hours: 6 AM - 6 PM
education: Associate Responsibilities What You'll Do
- Core Operations: Execute manufacturing operations by following approved procedures, batch records, and work instructions in a GMP-regulated environment.
- Cleanroom & Aseptic Processing: Perform cleanroom operations with discipline and consistency, supporting activities such as aseptic processing, formulation, filtration, mixing, filling, and dispensing.
- Quality & Documentation: Complete documentation in real-time using Good Documentation Practices (GDP) and data integrity standards while adhering to a human performance model for error prevention.
- Area & Safety Maintenance: Maintain the cleanliness, control, and readiness of the production area; follow all safety procedures, waste handling requirements, and environmental guidelines.
- Digital Systems: Utilize manufacturing systems and equipment such as SAP, Veeva, DeltaV, Syncade, LIMS, and CMMS.
- Technical Growth: Build a practical understanding of equipment, process flows, and digital systems to recognize issues, respond appropriately, and develop technical judgment.
- Collaboration & Escalation: Work closely with teammates and cross-functional partners, communicate clearly, and escalate issues early to ensure smooth operational execution.
- working weekends
- Manufacturing
- GMP
- cGMP
- Years of experience: 1 year
- Experience level: Entry Level
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 [email protected]. 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.
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