Senior QC Chemist

Aquestive Therapeutics•Portage, IN

10h

About The Position

This position is responsible for the preparation, processing, review, and release of commercial, stability, developmental and raw material samples within the established turnaround times in the Quality Control Laboratory. The successful candidate will organize, execute, and complete their daily activities in compliance with Aquestive’s Quality System and Quality Control Metrics.

Requirements

BS/BA degree in a scientific discipline, advanced degree is a plus.
5+ years’ experience in a pharmaceutical analytical laboratory or regulated environment.
Ability to handle multiple assignments and projects with competing priorities while independently managing time.
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.
Effective oral and written communication skills.
Proficient in computer use (Word, Excel, PowerPoint, etc.).
Strong technical writing skills.
Able to exercise independent intellectual judgment using data driven decision making.
Expert in working with and trouble-shooting analytical testing equipment.
Ability to take on additional tasks, as required.

Nice To Haves

advanced degree is a plus

Responsibilities

Performs routine testing, technical data review and data release for a variety of methodologies including HPLC, GC, Dissolution, FTIR, etc. across variety of different test samples (raw material, in-process/finished product, stability, validation, development, complaint, etc.)
Prepares and standardizes laboratory reagents and test solutions.
Documents all work in compliance with Good Documentation Procedures.
Generates data, reports and forms.
Reviews data packets for accuracy and compliance to GMP documentation practices and adherence to specifications.
Signs off on chromatographic data in Chromeleon Software.
Reviews, approves, and releases test results against specifications to Quality Assurance within the established turnaround times and in accordance with the product release dates provided by Quality Assurance
Promptly communicates with stakeholders regarding status, deadlines, delays, and investigations.
Prepares solutions and reviews peer solution preparation documentation for accuracy and GMP compliance.
Actively participates and/or leads technical transfer of methods from development phase to validated phase.
Authors and/or reviews specifications (in-process, finished product, raw material, etc.) in Master Control.
Routinely reviews compendia requirements for changes and/or application to internal specifications.
Operates, calibrates, performs preventative maintenance and when required trouble shoots and repairs minor problems with analytical instrumentation.
Actively participates and/or leads quality control investigations related to OOS/Event/Deviation/CAPA in partnership with peers and Quality Assurance.
Determine investigational plans.
Determines root causes for out of specification and atypical test results.
Develops and proposes corrective actions.
Supports product complaint investigations as required.
Authors, edits, and reviews technical documentation (ex. reports, protocols, specifications, SOPs, SAMs, Forms).
Performs departmental tasks as assigned, including sample receipt, sample submission to third party laboratories, DEA compliance documentation, chemical inventory, ordering of consumables and lab supplies, disposal of waste, dishwashing, general lab organization and cleaning.
Maintains regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other product or project specific documentation.
Performs all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.
Works closely with others in a team environment and acts as an integral team member on multidisciplinary project teams.
Continually reviews programs and systems to develop and drive improvements in efficiency, effectiveness, and quality.
Leads hands on training for analytical techniques.
Collates, analyzes, and summarizes data.
When required, interacts with internal and external auditors.
Communicates schedule delays to the QC Coordinator.