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Microbial Quality Assurance Specialist

2 months ago

San Antonio, Texas, United States Scorpius Biomanufacturing Full time
Job Overview

Scorpius BioManufacturing operates as a dedicated contract development and manufacturing organization (CDMO) specializing in biologics, situated in San Antonio, Texas. We provide comprehensive manufacturing, bioanalytical, and process development services tailored for protein modalities, catering to start-ups, emerging biotech firms, and academic research entities. Established by an experienced entrepreneur in the biotech sector, Scorpius emphasizes small-scale projects with a commitment to Quality, Agility, Flexibility, and Responsiveness.

Role Summary

The Microbial Quality Assurance Specialist position at Scorpius BioManufacturing entails executing sampling for environmental assessments, managing testing apparatus, and assisting with quality documentation within the quality management framework. Key responsibilities encompass conducting investigations, managing GMP documentation, adhering to GMP protocols, and enhancing capabilities across biomanufacturing facilities. The ideal candidate should exhibit meticulous attention to detail, organizational prowess, and excellent communication abilities.

Key Responsibilities
  • Contribute to departmental performance metrics and efficiency
  • Engage in daily operational activities and pinpoint areas for enhancement
  • Perform environmental assessments and microbiological testing
  • Assist in investigations and troubleshooting processes
  • Support the qualification of new utility systems
  • Address microbiology-related deviations
  • Ensure adherence to product/project timelines
  • Participate in aseptic process simulations
  • Facilitate regulatory inspections and responses
  • Contribute to data analysis and reporting
  • Employ problem-solving techniques to identify effective solutions
Essential Competencies
  • Ability to thrive in a dynamic work environment
  • Proficient in authorship and critical review processes
  • Strong communication skills with management
  • Customer-oriented with effective problem-solving capabilities
  • Independent thinker with persistence
  • Familiarity with aseptic manufacturing methodologies
  • Technical insight into biopharmaceutical production
  • Self-driven with robust organizational skills
Knowledge & Skills Required
  • Comprehension of test method validations and troubleshooting techniques
  • Strategic development and advisory skills
  • Conflict resolution and negotiation expertise
  • Proficient time management and organizational abilities
Educational Background & Experience
  • Bachelor's degree in Life Sciences, Biology, or Microbiology is preferred
  • A minimum of 2 years of relevant professional experience
Physical Demands & Work Environment
  • Flexibility in work hours is required
  • Combination of office and laboratory settings
  • Capability to lift and move items weighing up to 20 pounds
  • Manual dexterity for computer-related tasks
  • Vision capabilities are necessary