Quality Specialist (AQL) - 3rd Shift

Company: Aquestive Therapeutics, Inc.
Location: Portage
Posted on: June 8, 2021

Job Description:

Job Summary:

Performs AQL (Acceptable Quality Limits) attribute testing and required sampling on the batches of finished products produced by Aquestive.

Responsibilities:

• Pulls the AQL samples during packaging of finished product based on sampling instructions.
• Performs AQL testing by verifying appearance, weight, dimensions of pouch and strip, presence of print on strip and pouch, and seal integrity for each AQL sample pulled.
• Records results from each AQL test performed.
• Communicates AQL alert, action or failure limits to the Quality Assurance and Operation Supervisor.
• Segregates impacted population criteria based on AQL testing results and communicating criteria for such to the Operations Supervisor and packaging operators.
• Performs stability sampling, finished product sampling, micro and in process sampling and bringing samples to the lab, per the appropriate protocol or sampling instructions.
• Demonstrates good understanding of AQL procedures and guidelines after applicable training.
• Performs other duties as instructed by QA Supervisors.
• Trains and performs batch record review during production operations, line clearance and control procedures, IPC testing, scale/balance verification and other assigned production support duties as deemed appropriate.

Qualifications:

• Minimum 2-year college degree or equivalent experience.
• 2+ years in pharmaceutical or other regulated industry.
• Ability to understand and follow Standard Operating Procedures.
• Strong working knowledge of cGMPs.
• Ability to work within a team environment and willingness to contribute to the overall goals of the company.
• Proactive individual with strong organizational skills and outstanding attention to detail.
• Ability to communicate effectively, both orally and in writing.
• Basic math skills.
• Experience with Microsoft Office.
• Ability to lift up to 35lbs.

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 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.

Keywords: Aquestive Therapeutics, Inc., Gary , Quality Specialist (AQL) - 3rd Shift, Other , Portage, Indiana