Kaztronix
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Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials.
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.
Experience: Minimum of 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Analyst I, QC Microbiology
Job Description
- JOB SUMMARY
Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials.
- 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.
- Operation of a biohazard trash autoclave.
- Perform daily checks on equipment.
- Stock the lab on a daily basis.
- Cleaning the lab and equipment.
- Prepping of materials requiring sterilization.
- Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
- Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
- Write and review SOP's and Testing Standards as necessary.
- Review, analyze, interpret and report data.
- Verifies and enters approved results in laboratory information management systems (LIMS).
- Prepare disinfectant solutions, reagents, samples for analyses.
- Participate in investigations and other related studies.
- Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
- 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.
- Communication the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
- Planning/Organizing the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
- 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.
- 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.
Experience: Minimum of 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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