Kaztronix
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http://www.kaztronix.com
http://www.kaztronix.com
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I: JOB SUMMARY
This position actively supports routine product in-process, release, and stability testing for the site. This includes participation in transfer and implementation of new analytical methods into the site to support process optimization and manufacturing activities. This may include helping to develop and optimize incoming analytical methods, along with planning and executing verification and validation protocols.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Routine job responsibilities include, but are not limited to:
· Performs activities involved with transfer of test methods to and from, including performing method development, optimization, verification, and validation along with writing protocols and reports.
· Provides technical expertise for method development, optimization, verification, qualification and validation.
· Assists with planning and coordinating execution of method transfer activities including ordering of supplies and materials, purchasing equipment, preparation of documents, providing training, coordinating schedules and working with other Emergent sites and collaborators.
· Performs and/or supports investigations and quality change controls as necessary.
· Performs other duties as assigned in support of QC Analytical such as QC testing, equipment maintenance, material intake, and maintaining QC laboratory systems.
· Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
· Analyzes and formats data to support method evaluation and trending.
· Write SOPs and reports with minimal oversight.
· Evaluation of new technologies or new applications of established technologies that lead to improved product quality and lower costs by supporting process development through improving sample throughput in key analytical methods.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
· Bachelor' s degree in Biology, Biochemistry, Chemistry or closely related scientific discipline with 5 years of relevant experience or MS with a minimum of 3 years of relevant experience.
· Skills and knowledge in immunological and ligand-based test methods such as ELISA, Western Blot and SDS-PAGE testing is also desirable.
· Skills and knowledge of general chemical and bioanalytical test methods such as pH, Appearance, UV spectroscopy, TOC, CE, Gel electrophoresis, IEF and qPCR.
· Advanced knowledge of cGMPs, safety and data integrity as relevant to a QC laboratory.
· Experience in executing phase appropriate method qualifications and validations.
· Knowledge of viral based delivery systems and the methods used to analyze them is highly desirable.
· Excellent written and verbal communication skills including ability to write reports for method verification/qualification/validation.
· Experience with LIMS and SAP software applications is desired.
·
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Mental Demands:
Ability to organize/coordinate Comprehend and follow instructions
Direct, control and plan Independently make quick decisions to solve complex issues
Problem Solve Analyze/Interpret data and information
Perform with frequent interruptions Make decisions using sound judgment
Supervise/Manage others
Physical Demands:
Good eye/hand coordination Visual Acuity
Use keyboard/computer/phone Detect/Distinguish smell
Detect/Distinguish hearing Maintain stationary position
Position self to move Move/Traverse
Ascend/Descend (climb) Reaching
Calibrate precise Ability to safely operate hand tools
measurements
Move/Transport [X] lb. Repetitive movement activities
Environmental Characteristics:
Regular and predictable attendance
Work around extreme temperatures – cold or hot
Work around noise above conversation level
Work in restricted access to laboratory area
Exposure to dust/gas/fumes/steam/chemicals
Work with Select Agents as defined by the CDC
Work irregular hours that often include nights and weekends
Work in multiple locations
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 lll, QC Analytical
Baltimore, MD US
Posted: 05/25/2023
2023-05-25
2023-06-27
Industry: Scientific
Job Number: 23-00247
Job Description
I: JOB SUMMARY
This position actively supports routine product in-process, release, and stability testing for the site. This includes participation in transfer and implementation of new analytical methods into the site to support process optimization and manufacturing activities. This may include helping to develop and optimize incoming analytical methods, along with planning and executing verification and validation protocols.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Routine job responsibilities include, but are not limited to:
· Performs activities involved with transfer of test methods to and from, including performing method development, optimization, verification, and validation along with writing protocols and reports.
· Provides technical expertise for method development, optimization, verification, qualification and validation.
· Assists with planning and coordinating execution of method transfer activities including ordering of supplies and materials, purchasing equipment, preparation of documents, providing training, coordinating schedules and working with other Emergent sites and collaborators.
· Performs and/or supports investigations and quality change controls as necessary.
· Performs other duties as assigned in support of QC Analytical such as QC testing, equipment maintenance, material intake, and maintaining QC laboratory systems.
· Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
· Analyzes and formats data to support method evaluation and trending.
· Write SOPs and reports with minimal oversight.
· Evaluation of new technologies or new applications of established technologies that lead to improved product quality and lower costs by supporting process development through improving sample throughput in key analytical methods.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
· Bachelor' s degree in Biology, Biochemistry, Chemistry or closely related scientific discipline with 5 years of relevant experience or MS with a minimum of 3 years of relevant experience.
· Skills and knowledge in immunological and ligand-based test methods such as ELISA, Western Blot and SDS-PAGE testing is also desirable.
· Skills and knowledge of general chemical and bioanalytical test methods such as pH, Appearance, UV spectroscopy, TOC, CE, Gel electrophoresis, IEF and qPCR.
· Advanced knowledge of cGMPs, safety and data integrity as relevant to a QC laboratory.
· Experience in executing phase appropriate method qualifications and validations.
· Knowledge of viral based delivery systems and the methods used to analyze them is highly desirable.
· Excellent written and verbal communication skills including ability to write reports for method verification/qualification/validation.
· Experience with LIMS and SAP software applications is desired.
·
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Mental Demands:
Ability to organize/coordinate Comprehend and follow instructions
Direct, control and plan Independently make quick decisions to solve complex issues
Problem Solve Analyze/Interpret data and information
Perform with frequent interruptions Make decisions using sound judgment
Supervise/Manage others
Physical Demands:
Good eye/hand coordination Visual Acuity
Use keyboard/computer/phone Detect/Distinguish smell
Detect/Distinguish hearing Maintain stationary position
Position self to move Move/Traverse
Ascend/Descend (climb) Reaching
Calibrate precise Ability to safely operate hand tools
measurements
Move/Transport [X] lb. Repetitive movement activities
Environmental Characteristics:
Regular and predictable attendance
Work around extreme temperatures – cold or hot
Work around noise above conversation level
Work in restricted access to laboratory area
Exposure to dust/gas/fumes/steam/chemicals
Work with Select Agents as defined by the CDC
Work irregular hours that often include nights and weekends
Work in multiple locations
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.