Job Description
Job Summary:
This position is responsible for the preparation, processing, and reporting 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.
Job Responsibilities - Completes activities in compliance to applicable standard operating procedures, specifications, and compendia requirements in an efficient and high-quality manner.
- Performs testing, analysis, and data reporting for test samples.
- Executes analytical methods for testing on a variety of test samples including raw material, in-process/finished product, stability, validation, and R&D test samples as assigned.
- Prepares and standardizes laboratory reagents and test solutions.
- Meticulously documents work in compliance with Good Documentation Procedures.
- Generate data, reports, and forms.
- Operates, calibrates, performs preventative maintenance and when required trouble shoots and repairs minor problems with analytical instrumentation.
- Participates in investigations.
- Determines root causes for out of specification and atypical test results.
- Develops and proposes corrective actions.
- Supports customer complaint investigations as required.
- Performs all work according to applicable safety procedures using Good Laboratory Techniques and ensuring safe operation of laboratory equipment.
- Maintains 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.
- 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 cleaning.
- 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.
- Supports and executes activities for test method validation and transfer.
- Collates, analyzes, and summarizes data.
- When required, interacts with internal and external auditors.
Job Qualifications
- BS/BA degree in a scientific discipline, advanced degree is a plus.
- 2+ years' experience in a pharmaceutical analytical laboratory or regulated environment preferred.
- Ability to handle multiple assignments and projects with competing priorities.
- Highly motivated, 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.).
- 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 colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the 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.
Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Job Tags
Full time, Local area,