Quality Control; Bioassay​/Microbiology

Specialist, Quality Control (Bioassay/Microbiology) – Individualized Neoantigen Vaccine (INT)

The Opportunity:

• Pay Rate: Up to $45.00 per hour.
• Schedule: Monday – Friday, 1st Shift (Onsite).
• Duration: 6-month contract with a possibility for extension.
• Location: Norwood, MA.

Join this pioneering team in Norwood, Massachusetts, a cornerstone of our U.S. manufacturing footprint. As a Specialist in Quality Control (Bioassay/Microbiology) for our Individualized Neoantigen Vaccine (INT) program, you will play a vital role in our end-to-end mRNA platform integration. This is a high-impact leadership role where you will take ownership of daily lab operations, ensuring the scientific rigor and agility required to deliver individualized mRNA therapies to patients rapidly and safely.

Key Responsibilities:

• Operational Leadership:
  Lead shift-based lab execution, mentoring peers and coordinating workloads to ensure accuracy and speed in testing.
• Technical Oversight:
  Oversee assay capabilities, method transfers, and equipment troubleshooting for release and stability testing.
• Cross-Functional Collaboration:
  
  Act as a liaison between Manufacturing, QA, Regulatory, and Technical Development to ensure seamless workflows.
• Compliance & Documentation:
  Author and review technical reports, deviations, CAPAs, and SOPs; resolve assay failures and OOS/OOT results swiftly.
• Innovation & Digitalization:
  Identify opportunities to apply digital tools and data-driven systems to maximize lab impact and reduce cycle times.
• Quality Culture:
  Participate in sample management oversight and drive continuous improvement initiatives to establish best-in-class lab standards.

What You’ll Need (Basic Qualifications)

• Education:
  
  BS in a relevant scientific discipline.
• Experience:
  
  3–5 years of Quality Control experience in a cGMP environment.
• Technical Proficiency:
  Demonstrated expertise in Bioassays and Microbiology, specifically:
• qPCR, Sanger Sequencing, and Electrophoresis.
• Bioburden, Endotoxin, Sterility, and Cell Culture.
• Regulatory Knowledge:
  In-depth understanding of FDA, EU, and ICH guidelines.
• Systems & Planning:
  Experience with scheduling and project management; proficiency in digital quality systems such as LIMS, QMS, or CDS is preferred.
• Quality Management:
  Proven ability to handle Quality System Records, Deviations, Change Controls, and CAPAs.
• Soft Skills:
  
  Outstanding communication skills and the ability to thrive in a fast-paced, dynamic, cross-functional matrix environment.
• Digitize Everywhere:
  You look for ways to use code and data to improve reliability and turnaround times for our patients.
• Behave Like an Owner:
  You take full responsibility for lab readiness and technical excellence, proactively identifying gaps and mentoring colleagues.

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

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.