New · posted Oct 15
Aquestive Therapeutics · Pharmaceuticals
Manufacturing Quality Associate (MQA) - 2nd & 3rd shift
- Portage, IN
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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.
What you need
- 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.
What you'll do
- 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)
Where you'll work
Portage, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Portage, INEqual opportunity, accessibility and legal noticesAquestive Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $78,500 | $94,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Aquestive Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs10
- GMP and compliance7
- Collaboration and leadership6
- Lab testing and methods4
- Investigations and CAPA3
- Quality systems and risk3
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Aquestive Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Senior & Principal2 50%
- Director1 25%
- Associate & Specialist1 25%
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Manufacturing Quality Associate (MQA) - 2nd & 3rd shift at Aquestive Therapeutics
Open until filled.