Senior QC Microbiology Leader - Quality, Compliance & Ops

Recipharm

United States

On-site

USD 155,000 - 165,000

Full time

11 hours ago
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Job summary

Recipharm Advanced Bio seeks a Senior Manager, QC Microbiology to lead microbiological QC activities across client programs and manufacturing operations. You will ensure accurate testing, timely results, and strict data integrity in a GMP environment.

The role partners with QA, Manufacturing, Analytical Development, Validation, Regulatory Affairs, and Project Management to support development through commercial manufacturing, investigations, and continuous improvement in a fast-paced CDMO

Qualifications

  • Bachelor's degree in Microbiology or related field is required.
  • Minimum 8 years in GMP-regulated pharma/biotech environments.
  • Supervisory or management experience in QC Microbiology.

Responsibilities

  • Lead day-to-day QC Microbiology operations for multiple programs.
  • Oversee testing of raw materials, in-process and finished products; environmental monitoring.
  • Manage EMPQ, utilities testing, and trend reviews for contamination risks.
  • Lead investigations (OOS/OOT), CAPAs, and change controls with cross‑functional teams.
  • Maintain GMP compliance and data integrity across documentation.

Skills

GMP microbiology
Leadership
Environmental monitoring
Investigations
Data integrity
Documentation
Communication
Problem solving

Education

Bachelor's in Microbiology
Master's preferred

Job description

Recipharm Advanced Bio seeks a Senior Manager, QC Microbiology to lead microbiological QC activities across client programs and manufacturing operations. You will ensure accurate testing, timely results, and strict data integrity in a GMP environment.

The role partners with QA, Manufacturing, Analytical Development, Validation, Regulatory Affairs, and Project Management to support development through commercial manufacturing, investigations, and continuous improvement in a fast-paced CDMO

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