Senior QC Microbiology Analyst – GMP & Investigations

Resilience

West Chester (Chester County)

On-site

USD 75,000 - 116,000

Full time

14 days+
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Benefits offered by this job

Annual cash bonus
401(k) match
Healthcare benefits

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Senior Analyst, QC Microbiology to perform microbiological testing and ensure GMP compliance across materials, in-process, and environmental samples. The role includes authoring SOPs and serving as an SME for the EDMS system.

Responsibilities span data trend evaluation, investigations, process improvements, and cross-functional collaboration to uphold regulatory standards and quality records.

Qualifications

  • Prior GMP-regulated environment experience.
  • Strong knowledge of cGXP and production operations.
  • Excellent attention to details and problem-solving skills.

Responsibilities

  • Performs and documents microbiological testing on raw materials, in-process and finished products, and environmental samples.
  • Ensures GMP compliance through timely review of laboratory data and documentation.
  • Authors SOPs and serves as a subject matter expert for the EDMS system.

Skills

GMP compliance
cGXP knowledge
Attention to detail

Education

Bachelor’s degree in Microbiology

Tools

EDMS familiarity

Job description

Resilience, a technology-focused biomanufacturing company, seeks a Senior Analyst, QC Microbiology to perform microbiological testing and ensure GMP compliance across materials, in-process, and environmental samples. The role includes authoring SOPs and serving as an SME for the EDMS system.

Responsibilities span data trend evaluation, investigations, process improvements, and cross-functional collaboration to uphold regulatory standards and quality records.

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