732-661-0400

QC Specialist- Environmental Monitoring

  • Location: Houston, TX
  • Type: Direct Hire
  • Job #36588

Work with an innovative immuno-oncology company to provide T-cell development for meaningful cancer treatments!

Overview

The Quality Control Specialist will be responsible for supporting site wide environment monitoring (facility and personnel) while also supporting microbiological assays. Person in this position will work in a cGMP environment using aseptic technique.

Pay: $58k-$64k DOE

Schedule: Mon-Fri 8a-5p

**Unlimited PTO and covered medical benefits***

Position Responsibilities

  • Collect, process, and analyze environmental samples during routine environmental monitoring (EM) and in support of facility qualification
  • Support Aseptic Process Simulations (APS) by performing EM, personnel monitoring and completing APS related documentation.
  • Conduct microbiological media growth promotion, endotoxin and sterility testing of in-process samples and final drug product.
  • Perform basic maintenance, calibration and quality control of instruments used in EM.
  • Demonstrate an understanding of regulatory, compliance, and validation issues, as well as experience in writing and reviewing the associated technical documents.
  • Write and revise Standard Operating Procedures through change control, and performs project related tasks as assigned with detailed instruction.
  • Write, review, and/or approve test records/forms, sampling plans, and specifications with a focus on Good Documentation Practices (GDP).
  • Work in cooperation with Quality Assurance to design validation qualification protocols and activities for new equipment and materials. May participate in the execution of such protocols as needed to support lab(s) and manufacturing operations.
  • Assist with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA).
  • Complete data analysis and summary reports for scheduled trend reports.

Skills, Education And Experience Required

  • Minimum Bachelor’s degree in life Sciences, preferably microbiology
  • 2-years of experience working in pharmaceutical/biopharmaceutical ISO 5 environment
  • Knowledge of cGMP and experience with Aseptic processing
  • Knowledge of/ability to learn rapid microbiological methods and microbial identification system
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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