Portage, Indiana, United States · On-site
Summary: Follows the lead of the Packaging Specialists during the packaging of a batch and during the closing of a batch. Inspects the finished product before placing the finished product into a carton. Checks the qualit…
Skills: Packaging, Quality Inspection, cGMP Compliance, SOP Adherence, Documentation
Portage, Indiana, United States · On-site
Summary: Responsible for a basic knowledge of all phases of the production operation from weighing through coating. On each shift, each Manufacturing Technician will be responsible for one of the following production ope…
Skills: Weighing, Mixing, Coating, Slitting, Equipment Calibration
Portage, Indiana, United States · On-site
Job Summary: The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. …
Skills: CMC Quality, Analytical Science, OOS Investigations, OOT Investigations, Root Cause Analysis
Portage, Indiana, United States · On-site
Job Summary: Responsible for leading day-to-day quality oversight of manufacturing and operational activities to ensure compliance with cGMP, regulatory requirements, and company quality systems. Drives execution, inspec…
Skills: cGMP Compliance, Quality Operations Management, Risk Assessment, CAPA, Root Cause Analysis
Portage, Indiana, United States • On-site
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The associate supports Packaging Specialists in packaging and closing batches while performing in-process quality checks. They are responsible for documenting findings in batch records and ensuring the finished product meets required specifications before cartoning.
A High School Diploma or GED is required, with basic math and communication skills. Candidates must be able to lift up to 50 pounds and be willing to work various shifts in a fast-paced, regulated environment.
Summary:
Follows the lead of the Packaging Specialists during the packaging of a batch and during the closing of a batch. Inspects the finished product before placing the finished product into a carton. Checks the quality of the finished product by performing in process checks and documenting findings in batch record. Notifies Quality and Production Supervisors if the product fails the required specifications.
Responsibilities:
• Maintains a cGMP area.
• Follows all required SOPs and work instructions and safety procedures.
• Documents all required information to ensure compliance.
• Performs in-process checks efficiently.
• Supports packaging operators during the opening and closing of a batch.
• Places finished product into cartons and seals.
• Supports daily and weekly cleans.
• Follows all DEA requirements to ensure compliance to regulations.
• Other projects and duties as assigned.
Qualifications:
• High School Diploma or GED required; college degree desired for future opportunities within Aquestive.
• Possess basic mathematical skills: addition, subtraction, multiplication, and division.
• Ability to communicate effectively both orally and written.
• Desire to work in fast paced, heavily regulated environment that requires significant attention to detail; high degree of accuracy and utmost integrity to ensure the safety and efficacy of our products.
• Willingness to work various shifts in a 24/7 operation.
• Strong attention to detail to ensure effective inspection.
Willingness to be proactive; comfortable in raising concerns regarding inspection results.
• Ability to take specific direction, with no room for error.
• Ability to work in a team environment, and collaborate effectively across teams, functions, and shifts.
• Ability to lift up to 50 pounds.
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.
A pharmaceutical company advancing medicines to solve patients’ problems with current standards of care.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four licensed commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel product candidate for various possible dermatological conditions, including alopecia areata.
Offices: 30 Technology Drive, Warren, New Jersey 07059, US
A pharmaceutical company advancing medicines to solve patients’ problems with current standards of care.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four licensed commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel product candidate for various possible dermatological conditions, including alopecia areata.
Offices: 30 Technology Drive, Warren, New Jersey 07059, US
