Analyst III, QC Raw Materials

Baltimore, MD

Posted: 05/23/2023 Industry: Scientific Job Number: 23-00244

Job Description

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.
  • 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

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.

Meet Your Recruiter

Marion Bowden

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