QC Analytical Chemist

Aquestive Therapeutics, Inc. Portage , IN 46368

Posted 3 weeks ago

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Description

Reporting to the Manager of Quality Control, the Analytical Chemist is 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

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

  • Complete activities in compliance to applicable Aquestive procedures, specifications, and compendia requirements in an efficient and high quality manner.

  • Perform testing, analysis and data reporting for test samples.

  • Execute 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 samples.

  • Prepare and standardize laboratory reagents and test solutions

  • Document work with particular attention to detail and in compliance with Good Documentation Procedures.

  • Generate Data Reports and Forms .

  • Operate, calibrate, perform preventative maintenance and when required trouble shoot and repair minor problems with Analytical Instrumentation.

  • Support and execute activities for test method validation and transfer.

  • Participate in test method development.

  • Author, edit, and review technical reports, protocols, specifications and SOPs.

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

  • Participate in and/or lead independent and team based investigations .

  • Determine root causes for Out of Specification and Atypical test results.

  • Develop, propose and monitor corrective actions.

  • Support customer complaint investigations as required.

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

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

  • Lead hands on training for analytical techniques.

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

  • Act as peer technical and quality assurance review for lab ratory work performed.

  • Display good problem solving ability.

  • Collate, Analyze and Summarize data.

  • Participate 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 cleaning.

  • When required interact with internal and external auditors.

Requirements

  • BS/BA degree in a scientific discipline, 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:

Strong technical writing skills

  • Able to exercise independent intellectual judgment using data driven decision

making

  • Excellent oral and written communication skills

Expert in general analytical techniques

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

  • Ability to take on additional tasks, as required.

The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


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QC Analytical Chemist

Aquestive Therapeutics, Inc.