• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Sr. Analyst, QC

Job Number: 34648

Location:

Job Description

A biotech company seeks an experienced Quality Control Senior Analyst for daily operations in the QC Microbiology group. Responsibilities include sampling a cGMP manufacturing facility, testing samples for batch release of advanced therapeutics, executing environmental and utilities monitoring programs, coordinating with external vendors, investigating atypical results, supporting trend analysis, and leading continuous improvement initiatives. The candidate will collaborate with department management and may support external provider investigations as needed.

Responsibilities

  • Executing environmental monitoring programs and microbiology testing for an internal manufacturing facility.
  • Leading microbiology testing.
  • Performing day-to-day operations in GMP manufacturing facilities.
  • Ensuring compliance in operations.
  • Leading continuous improvement initiatives.
  • Generating periodic reports for cleanroom environment, utilities, and microbial isolates.
  • Leading investigations.
  • Ensuring current training for assigned responsibilities.
  • Working safely and responding to safety inspections and audits.

Required Skills

  • Life sciences degree (BSc, MSc, PhD, or equivalent) with at least 8 years of pharmaceutical industry experience, including 4+ years in Quality Control EM/Micro roles.
  • Experience with cell and gene therapy products is desirable.
  • Knowledge of requirements for pharmaceutical development and manufacturing, including expertise in standard methods.
  • Experience in regulatory inspections and dealing with compliance issues is preferred.
  • Self-motivated individual capable of handling multiple priorities to meet project goals and timelines.
  • Excellent written and verbal communication skills.

 

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