Quality Assurance Specialist
Listed on 2026-10-11
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Healthcare
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Quality Assurance - QA/QC
is a rapidly growing consumer technology firm operating a suite of healthcare businesses, including our flagship brand Blue Chew & MOD. Our mission is to better patients' lives through innovative healthcare solutions. With a team of 350 professionals across various specialties, we've built scalable pharmacy, telemedicine, and e-commerce platforms using cutting-edge technology. As we continue our accelerated growth trajectory, we're launching new products to expand our patient base and accelerate growth.
Join us in tackling exciting challenges at the intersection of healthcare and technology.
We’relooking for a meticulous, quality-focused
Quality Assurance Specialist
to join our team at our Elmhurst pharmacy facility. In this role, you will play a critical part inmaintainingthe highest standards of product safety, regulatory compliance, and operational quality across our daily compounding and fulfillment processes.
Working directly on the pharmacy floor, you will collaborate closely with pharmacy operations and the broader QA team to audit processes, perform batch record reviews, inspect incoming materials, and ensure full adherence to standard operating procedures (SOPs) and state/federal regulations. If you thrive in a fast-paced environment and have a keen eye for detail, you will help us ensure every patient receives safe, top-quality care.
Join our team in Elmhurst, IL
-we'relooking for someone who truly values and enjoys working onsite, not just tolerates it.
- Serves as primacy quality records coordinator and QA Manager with broader quality assurance initiatives.
- Support Quality lead on announced and unannounced inspections
- Support 5S goals to create andmaintaina better organized, safer, cleaner, and more efficient workplace.
- Support the development, review, and updating of pharmacy policies, procedures, logs/forms, and training materials.
- Maintain a strong knowledge base in current regulatory requirements pertaining toUSP non-sterile compounding.
- Manage SOPs and Forms Control index.
- Ensure policies and procedures are compliant with current regulatory, health, and safety standards.
- Coordinate monthly QA meetings and related items as requested under the direction of the Director of Quality assurance.
- Supports onboarding new hires byinitiatingtraining.
- Support the management of training through quizzes andupdateas needed when policies or procedures are developed.
- Manage andretaintraining logs for team members that are assigned training as completed.
- Assistin coordinating annual training.‘
- Responsible formaintainingrecords of all pharmacy activities including but not limited to:
- Collection and review of BPRs
- Document dailymonitorof temperature and humidity for pharmacy on a monthly/quarterly basis.
- Manage filing of SDS, equipment list, CAPAs, cleaning logs, and otherdocumentsrecord retention.
- Develop andmaintainmonthly logbooks pertaining toQA and Operations (e.g., Cleaning Checklists and Waste Logs).
- Provide support in the collection and documenting data trends.
- In collaboration withoperationsmaintainequipment calibration records and monitor schedules.
- Monitor and document Monitor FDA weekly enforcement logon a monthly basisfor any recalls that couldimpactraw ingredients or materials received.
- Reviews all Certificate of Analysis of products provided by contract manufacturers, which need to be documented and properly stored.
- Retain any waste disposal documentation associated.
- Assistsinmaintaininga safe work environment byassistingin safety programs, and by conducting safety audits (Hazards Training Program, Spill Kits, Eye Wash)
- Assistin conducting and documenting annual drills and staff demonstrations in hazardous training program.
- Conduct and document monthly RO pH testing.
- Coordinate and document…
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