Advanced Research Associate - Aseptic Processing
Listed on 2026-07-10
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Manufacturing / Production
Quality Engineering, Regulatory Compliance Specialist, Production QC/QA -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Production QC/QA
Position Summary
The Advanced Research Associate supports the development and sustained manufacture of a product portfolio, executing and revising SOPs, facilitating controlled experiments, and collaborating cross-functionally to advance new and existing products. Implements process improvements, ensures compliance with quality standards, and supports operational excellence in a fast-paced environment.
Key Responsibilities- Author, revise, and execute Standard Operating Procedures (SOPs) for manufacturing reagents and consumables.
- Facilitate moderately complex controlled experiments for new product development.
- Perform validation activities for equipment used in GMP manufacturing.
- Follow Good Documentation Practices (GDP) to capture results, analyze data, and prepare reports.
- Perform timely reviews of in-process manufacturing documentation.
- Identify and resolve manufacturing process issues.
- Investigate and author non-conformance reports; lead troubleshooting.
- Propose and implement process improvement initiatives.
- Conduct workspace walkthroughs, close out actions, and perform device calibrations.
- Collaborate cross-functionally to achieve project objectives.
- Perform training for new employees and contribute to team development.
- Comply with safety, quality, and regulatory requirements.
- Bachelor’s degree with 3–5 years relevant experience, or Master’s degree with up to 2 years relevant experience.
- GMP laboratory experience required.
- Knowledge of GMP and GDP required.
- Strong aseptic filling knowledge.
- Exposure to media fills and aseptic process qualification.
- Ability to work in laminar flow hoods and RABS.
- Proficiency in Microsoft Word, Excel, PowerPoint.
- Ability to perform moderately complex data analysis and calculations.
- Strong organization, attention to detail, communication, and ability to train.
Onsite during standard business hours; occasional extended hours as needed.
Physical RequirementsStand/sit for extended periods; wear PPE/clean room attire; manual dexterity; lift up to 25 lbs.
BenefitsCompetitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and d. 401k, ESPP, HSA, FSA, Dependent Care FSA.
Application InstructionsIf you require a reasonable accommodation during the application/interview/recruitment process, contact
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