Manufacturing Quality Associate (MQA) - 2nd & 3rd shift

Aquestive-Therapeutics-Inc; Portage (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Aquestive Therapeutics, Inc. seeks a Manufacturing Quality Associate to oversee quality and compliance in day-to-day manufacturing operations on 2nd and 3rd shifts in Portage, IN. The role partners with operations, supply chain, engineering, and QC to support product quality.

The MQA will provide GMP oversight against SOPs, WI, and protocols, manage CAPAs and environmental monitoring, and lead quality projects to improve efficiency and compliance. Two shifts available, with off-hours expected.

Qualifications

• Knowledge of quality systems, GMPs, industry standards, and regulatory requirements for pharma manufacturing.
• Formal training in quality disciplines (auditing, engineering, process improvement) such as ASQ or Lean Six Sigma is highly preferred.
• Ability to review/audit production records, reports, and GMP documentation.

Responsibilities

• Monitors manufacturing operations to ensure adherence to AQST policies and procedures and provides guidance to colleagues on product quality.
• Performs routine internal audits and facility walkthroughs to maintain audit readiness.
• Initiates and investigates nonconformances; leads project management to resolve quality issues with cross-functional teams.
• Authors and reviews Forms, Batch Records, WI, SOPs, and Protocols in the electronic document system.
• Investigates product quality complaints using manufacturing and quality process knowledge.
• Owns CAPA records and implement actions with cross-functional teams to ensure timely and effective corrective actions.
• Coordinates Environmental Monitoring including scheduling third-party water testing, sampling, and reporting.
• Leads quality improvement projects to enhance efficiency and compliance within 3–12 months.
• Ensures quality support aligns with manufacturing schedules and supports business continuity.
• Performs real-time review of batch records and other operational records for required corrections.
• Conducts AQL testing on finished products for attributes like appearance, dimensions, printing accuracy, and seal integrity.
• Performs line clearances for all steps of manufacturing.

Skills

Quality systems knowledge

GMP knowledge

Regulatory compliance

Education

Bachelor's degree in chemistry/biochemistry or related field

Job description

Manufacturing Quality Associate (MQA) - 2nd & 3rd shift

Job Category: Operations

Requisition Number: MANAG001494

• Posted : September 29, 2026
• Full-Time
• On-site

Locations

Showing 1 location

Aquestive Therapeutics, Inc.
Portage, IN 46368, USA

Description

Job Summary:

The Manufacturing Quality Associate is responsible for ensuring quality and compliance during the day-to-day operations in the manufacturing environment by partnering with operations, supply chain, engineering, quality control, or other functions to support product quality. This role provides GMP oversight through guidance against internal SOPs, WI, Protocols and Records as it pertains to manufacturing activities for development and commercial manufacturing.

Responsibilities:

• Monitors all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures and provides guidance and clarity to colleagues to ensure consistent approaches to product quality are applied.
• Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements and to maintain a state of audit readiness.
• Initiates and investigates nonconformances, project managing to resolve quality issues by partnering with other functions.
• Author and review Forms, Batch Records, WI, SOPs, Protocols in electronic document management system
• Investigates assigned product quality complaints utilizing knowledge of the manufacturing and quality processes at Aquestive
• Owns CAPA records and action item implementation, partnering with operations, supply chain, engineering, and QC staff to ensure corrective actions are implemented according to approved timelines and ensuring their effectiveness post-implementation.
• Coordinates the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation
• Short to medium term (3-12 months) project owner for quality projects to improve efficiency or compliance profile
• Understands the manufacturing schedule and provides quality support to ensure business continuity and seamless transitions between manufacturing stages.
• Operates with a sense of urgency in a fast-paced environment.
• Performs real time review of operational records, including Batch Records, and assists in obtaining any required corrections.
• Performs AQL Testing on finished product by verifying various attributes such as product appearance, product and packaging dimensions, presence and accuracy of printing on strip and pouch, and seal integrity.
• Performs line clearances for all steps of the manufacturing process.
• Reviews, assesses, and archives pest control documents.
• Maintains QA Retain Program, including sampling, inventory management and inspections required per internal SOPs.
• Leads process for ensuring manufacturing environment is in a state of control through the evaluation of the building automated system software, in partnership with Maintenance.
• Determines, documents and communicates when facility may be released back to cGMP operations after a shutdown, environmental excursion, etc.
• Performs other duties as instructed by quality management.
• Acknowledges that this position requires off-hours and weekend work from time to time to assure adequate QA floor support.
• *There are two (2) positions available. 12:00PM-8:30PM (2nd shift, staggered), and 12AM-8:30AM (3rd shift)

Qualifications:

• BS degree required preferably in chemistry, biochemistry, or related science field.
• 5+ years of related experience in the pharmaceutical, biotechnology, or medical device industry responsibility preferred.
• Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
• Formal training in Quality disciplines (auditing, engineering, process improvement) as demonstrated through certification (ASQ, Lean Six Sigma, etc) highly preferred
• Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.
• Ability to work within a team environment and willingness to contribute to the overall goals of the company.
• Ability to lead project teams
• Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
• Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels.
• Must be willing to work off hour shifts and weekends as necessary.

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.

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.