• , US

Company:  Confidential

Job Title: Analyst II/Sr. Analyst, QC, Environmental Monitoring

Job Number: 79513

Location: , US

Job Description

A company is seeking an experienced QC Analyst II/Senior Analyst to manage daily QC Microbiology tasks in a cGMP facility. Responsibilities include sampling, testing for batch release of advanced therapeutics, and executing environmental monitoring programs. The role involves coordinating with vendors, investigating atypical results, and supporting improvement initiatives. The candidate will work with management to ensure EM program success and may assist in external provider investigations.

Responsibilities

* Responsible for executing environmental monitoring programs and microbiology testing at an internal manufacturing facility. * Lead microbiology testing for Vor’s EM program and product support, both internally and externally. * Execute daily EM/Micro operations in GMP manufacturing facilities. * Ensure adherence to cGMP practices in QC Microbiology lab operations and testing. * Lead continuous improvement initiatives related to EM. * Generate periodic reports for cleanroom environment, utilities, and microbial isolates. * Lead investigations for EM excursions, microbial investigations, and out-of-specification results. * Ensure current training for assigned responsibilities. * Work safely and respond to safety inspections and audits as needed.

Required Skills

* Life sciences degree (BSc, MSc, PhD, or equivalent) with 8+ years in pharmaceuticals, including 2+ years in Quality Control EM/Micro roles. * Preference for experience in cell and gene therapy products. * Knowledge of cGMP, ICH requirements, and standard compendial methods. * Experience in regulatory inspections and compliance preferred. * Self-motivated with strong multitasking abilities. * Excellent written and verbal communication skills.

Application Deadline: 2024-07-08

 

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