Analytical Chemist I

Job Summary:

Responsible for hands on laboratory testing and analysis of test samples in order to ensure the overall quality of processes, raw materials and finished products are aligned with specifications, industry standards and regulatory requirements while maintaining highest level of customer satisfaction .

Responsibilities:

• Works closely with others in a team environment within the Quality Control laboratory and acts as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development activities.

• Completes activities in compliance with applicable Aquestive procedures, specification s , and compendia requirements in an efficient and high -quality manner.

• Performs testin g , analysis and data reporting for test samples.

o Executes analytical methods for testing on a variety of test samples including raw material, in-process/finished product, stability, validation , Process Development and R&D test sample s .

o Prepares and standardizes laboratory reagents and test solutions.

o Documents work with particular attention to detail and in compliance with Good Documentation Procedures .

o Generates Data Reports and Forms .

• Operat es , calibrat es , performs preventative maintenance and when required trouble shoots and repairs minor problems with Analytical Instrumentation.

• Utilizes laboratory software for sample/test processing.

• Support s and executes activities for test method validation and transfer.

• Participates in test method development.

• Author s , edi ts , and reviews technical reports, protocols, specifications and SOP s .

• Continually reviews programs and systems to develop and drive improvements in efficiency, effectiveness and quality.

• Participates in and/or leads independent and team based investigations .

o Determines root causes for out - of - specification, atypical and out-of-trend test results.

o Develops, proposes and monitors corrective actions.

o Support s customer complaint investigations as required.

• Performs all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.

• Demonstrates a basic fundamental understanding of mathematics and intermediate skills in computer use (Wor d , Excel, PowerPoint etc.) including ability to learn and master new computer applications.

• Leads hands on training for analytical techniques.

• Maintains regulatory compliance in instrumentation records , test result documentation, usage logbook s , maintenance logbooks and all other product or project specific documentation with particular attention to accurate record keeping.

• Act s as peer technical and quality assurance review for laboratory work performed.

• Displays good problem solving ability.

• Collates, analyzes and summarizes data.

· • Participates in general laboratory duties such as sample receipt, Sample submission to third party laboratories, DEA compliance documentation, chemical inventory, ordering and disposal, dishwashing, general lab organization and cleanin g .

• When required interacts with internal and external auditors.

Qualifications:

- BS/BA degree in a scientific discipline, preferred; advanced degree is a plus.

- 2+ years ’ experience in a pharmaceutical analytical laboratory or regulated environment is a plus.

• Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.

• Highly motivated, self - directed, detail oriented, quality minded with strong organizational skills.

• Operates with a sense of urgency in a fast-paced environment.

• Ability to comprehend and follow standard operating procedures and test methods.

• Knowledgeable in general analytical techniques with working knowledge of chromatography, spectroscopy and standard wet chemistry techniques.

• Knowledgeable in analytical testing equipment and related procedures.

• Effective oral and written communication skills.

• Proficient in computer use (Word, Excel, PowerPoint etc.), with ability to learn and master new computer applications.

• Highly desired qualifications include:

o Strong technical writing skills

o Able to exercise independent intellectual judgment using data driven decision making

o Excellent oral and written communication skills

o Expert in general analytical techniques

o Expert in working with and trouble-shooting analytical testing equipment

• Ability to take on additional tasks, as required.

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