Piper Companies · 19 hours ago
QC Micro Consultant
Piper Companies is seeking a QC Specialist, Micro to join a leading biotechnology company developing next-generation allogeneic cell therapies for oncology. The role involves performing endotoxin and sterility testing, supporting microbiological investigations, and ensuring compliance with GMP requirements.
Management Consulting
Responsibilities
Perform endotoxin testing (e.g., LAL, kinetic chromogenic/turbidimetric methods) in accordance with GMP requirements
Execute sterility testing (USP) and support investigations related to sterility failures or excursions
Conduct and/or support rapid microbiological testing methods, as applicable
Provide Environmental Monitoring (EM) support, including viable and non-viable monitoring of classified cleanrooms
Review, document, and trend microbiological data; identify deviations and support root cause investigations
Support method troubleshooting, assay qualification/validation, and continuous improvement initiatives
Ensure all testing and documentation complies with cGMPs, USP, and internal SOPs
Collaborate cross-functionally with Manufacturing, QA, and other QC teams during routine operations and audits
Assist with audit readiness and regulatory inspections as needed
Qualification
Required
Bachelor's degree in Microbiology, Biology, or a related scientific discipline
3–7+ years of QC Microbiology experience in a GMP pharmaceutical, biotech, or cell/gene therapy environment
Hands-on experience with: Endotoxin testing, Sterility testing, Rapid microbial methods, Environmental Monitoring programs
Strong knowledge of cGMPs and relevant USP chapters
Experience documenting and investigating microbiological deviations and excursions
Ability to work independently in a fast-paced, regulated environment
Benefits
Medical
Dental
Vision
Sick Leave as required by law
Company
Piper Companies
At Piper, we obsess about the success of our customers and consultants.
H1B Sponsorship
Piper Companies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (5)
2024 (1)
2023 (2)
2022 (2)
2021 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase