QC Specialist, Microbiology

Location: Branchburg, NJ (Onsite) – Contract role in Cell & Gene Therapy / Biopharmaceutical Manufacturing.

About the role

Piper Companies is seeking an experienced QC Microbiology Consultant to support quality control operations for a leading biotechnology organization focused on advanced therapies. This role will support GMP microbiology testing activities, with a strong emphasis on rapid sterility testing and microbiological quality systems.

Responsibilities

• Perform rapid sterility testing using the BacT/ALERT® system.
• Execute microbiological testing in accordance with cGMP requirements and internal procedures.
• Support method validation, qualification, and implementation activities.
• Perform rapid endotoxin testing.
• Conduct environmental monitoring of classified manufacturing areas.
• Document laboratory activities accurately and in compliance with GMP documentation practices.
• Assist with investigations, deviations, and CAPA activities as needed.
• Collaborate with cross-functional teams to support manufacturing operations and product release timelines.

Requirements

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.
• Experience working in a GMP pharmaceutical, biotechnology, biologics, or cell and gene therapy environment.
• Hands-on experience performing rapid sterility testing using BacT/ALERT® (required).
• Strong understanding of aseptic techniques and microbiological testing principles.
• Familiarity with GMP documentation and regulatory requirements.

Preferred Qualifications

• Experience with microbiological method validation or method transfers.
• Hands-on experience with rapid endotoxin testing.
• Environmental monitoring experience in cleanroom manufacturing environments.
• Experience with bioburden testing and traditional endotoxin testing.
• Previous experience supporting biologics, cell therapy, gene therapy, or sterile manufacturing operations.

Pay

$85,000–$95,000 on a W2 contract rate, depending on experience.

Benefits

• Medical
• Dental
• Vision
• Sick Leave as required by law
• PTO