Analyst II, QC Microbiology 3rd Shift - Baltimore, United States - Kaztronix LLC

Description

The Analyst II, QC Microbiology position supports the Quality Control group to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Perform various microbiological testing procedures as per Manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc.
• Perform environmental monitoring and utility testing of the facility.
• Performs environmental monitoring during fill operations.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Inform supervisor/manager upon observing OOS, OOL, or generation of deviations
• Participate in investigations of OOS results and other related studies.
• Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Investigate and suggest new laboratory procedures/techniques.
• Validate and implement new laboratory procedures/techniques.
• Update existing or write new testing standards and standard operating procedures.
• Train Microbiologist I & II in methods and techniques
• Review, analyze, interpret and report data.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Write and review monthly reports as necessary
• Track time worked per project.
• Participate in and attend professional seminars, conferences and conventions.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

• Technical/Professional Knowledge — having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
• Problem Solving — the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
• Safety and Security —the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
• Communication — the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
• Quality Management — the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
• Planning/Organizing — the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
• Adaptability – maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
• Stress Tolerance — maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.

Education: BS in Microbiology/Biology or related field

Experience: Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.