Kaztronix
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Analyst III, QC Raw Materials
Baltimore, MD US
Posted: 05/23/2023
2023-05-23
2023-06-27
Industry: Scientific
Job Number: 23-00244
Job Description
I: JOB SUMMARY
Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend and implement corrective actions.
II: ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
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
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.
Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend and implement corrective actions.
II: ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Supports the implementation of the raw material program
- Prepares specifications, SOPs, and method verification protocols and reports
- Ships samples and monitors test results produced by contract testing laboratories
- Communicates with raw material manufacturers to implement testing methodologies
- Schedule daily activities in routine testing of raw materials and cleaning samples
- Performs required data analysis, compiles data, and prepares results for review
- Conducts wet chemistry, chromatographic, and spectroscopic testing
- Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified
- Supports raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned
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 Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience
- Experience with spectroscopic methods, chromatography, and wet chemistry methods
- Familiarity with global pharmacopeias and monograph testing
- Ability to follow SOPs and comply with cGMPs; generate SOPs
- Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics
- Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography
- Experience working in a pharmaceutical testing environment
- Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff
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.