Specialist, Quality Control, Bioassay/Microbiology

job summary:
As a Specialist, Quality Control, Bioassay/Microbiology within the company''s cutting-edge Individualized Neoantigen Vaccine (INT) program, you will take ownership of daily lab operations while ensuring scientific rigor, regulatory compliance, and operational excellence. You will coordinate the delivery of raw material, drug substance, and finished product testing while supporting GMP operations from method transfer to deviation resolution. Your expertise will be critical in maintaining the precision, agility, and integrity required to deliver individualized mRNA therapies to patients rapidly and safely.

location: Norwood, Massachusetts
job type: Contract
salary: $35 - 41 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Leading QC testing operations in Bioassay and Microbiology within the INT program, ensuring accuracy, quality, and speed.
• Overseeing implementation of assay capabilities, method transfers, and equipment troubleshooting across release and stability testing.
• Ensuring consistent execution of stability and release testing aligned with 'Right First Time' principles.
• Acting as interdepartmental liaison to Manufacturing, QA, Regulatory, and Technical Development to ensure seamless workflow and compliance.
• Coordinating with development groups on assay qualification and technology transfer to support clinical and commercial timelines.
• Supporting internal and vendor audits and maintaining a robust GMP-compliant environment.
• Authoring and reviewing technical documents, major reports, deviations, CAPAs, and SOPs.
• Resolving assay failures, OOS/OOT results, and system deviations swiftly and accurately.
• Leading lab execution during shifts, mentoring peers, and coordinating workload across staff.
• Driving continuous improvement initiatives to reduce cycle time and increase lab efficiency.
• Supporting documentation management (review cycles, periodic updates, and change controls).
• Participating in sample management oversight to ensure timely delivery and readiness for testing.
• Contributing to safety and quality culture by owning remediation practices and establishing best-in-class standards in lab operation.
• In this lab leadership role, you'll be encouraged to identify opportunities where digital tools and data-driven systems can be applied to testing workflows, troubleshooting, and documentation processes, directly improving turnaround time and reliability in patient-critical testing.
• As a scientific leader in the QC space, you'll take full ownership of lab readiness, technical excellence, and coordination of deliverables - proactively identifying gaps, mentoring colleagues, and stepping in when needed to ensure flawless execution.

#LI-LH1

qualifications:
Required

• BS in a relevant scientific discipline with a minimum of 3-5 years Quality Control experience in a cGMP environment.
• In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
• Demonstrated proficiency with QC Pharmaceutical Bioassays and Microbiology to include: qPCR, Sanger Sequencing, electrophoresis, Residual Protein Assays, Bioburden, Endotoxin, Sterility and Cell Culture.
• Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.
• Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
• Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
• Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.
• Outstanding communication skills (verbal and written).
• Ability to manage multiple projects in a fast-paced environment.
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

skills: Microbiology, Laboratory Information Management Systems (LIMS), Cell Cultures, Capillary Electrophoresis (CE), Polymerase Chain Reaction (PCR), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Food and Drug Administration (FDA), International Council for Harmonization (ICH), Quality Management Systems (QMS)


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.