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# QA/ QC Associate (Pharmaceutical)

- **Company:** AdientOne LLC
- **Location:** Rockville, MD, United States
- **Experience:** Experienced
- **Salary:** $56,160.0 - $62,400.0
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Document Management Systems, Microsoft Office, Data Analytics
- **Published:** July 7, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=f25a79deb360b5a4

## About the Role

Bachelor's degree in relevant Science or Engineering discipline preferred.

 * Minimum 3 years working within industry. Strong technical writing capabilities a plus.
 * Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred
 * Knowledge of process improvement and lean methodologies preferred.
 * Ability to interpret and present complex scientific data in a clear and concise manner.
 * Proficient in Microsoft office suite and document management systems. Strong organizational and project management skills., * Do you have Bachelor's degree in relevant Science or Engineering discipline ?
 * Do you have experience within cell/gene therapies, biologics, and/or cGMP regulated environment?
 * Do you have a minimum of 3 years working within pharma industry?

## Description

* The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, continuous improvement initiatives to ensure Manufacturing consistently produces quality product.
 * This role sits at the intersection of operational excellence, quality, training & development, and MSAT supporting efficient, compliant, and ever improving operations.
 * The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.

Key Responsibilities and Duties: Process Improvement & Optimization

 * Identify and implement continuous improvement projects using Lean methodologies to improve and stabilize yield, efficiency, and process success.
 * Partner with MS&T and Process Development to monitor process performance to identify data driven solutions and enhancements.
 * Support technology transfer, process scale-up, and process validation to ensure smooth transitions into manufacturing.
 * Partner with MS&T and Engineering to optimize equipment utilization, automation strategies, and data analytics for real time adjustments and support. Compliance & Manufacturing Support
 * Conduct timely batch record reviews and deviation investigations, ensuring long term resolution of documentation/instructional issues.
 * Lead root cause analysis and corrective/preventive action (CAPA) for process deviations, nonconformance's, and quality issues.
 * Work close with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) incompliance with FDA, EMA, guidelines.

Training and Documentation Management

Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.

 * Partner with MS&T and Training to conduct training programs for manufacturing staff to ensure adherence to cGMP, process guidelines, and quality requirements.
 * Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.


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