Quality Assurance Specialist

Overview

is a rapidly growing consumer technology firm operating a suite of healthcare businesses, including our flagship brands BlueChew and MOD. Our mission is to better patients' lives through innovative healthcare solutions. With a team of over 500 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’re looking 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 in maintaining the 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're looking for someone who truly values and enjoys working onsite, not just tolerates it.

Responsibilities

• 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 and maintain a 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 to USP 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 by initiating training.

• Support the management of training through quizzes and update as needed when policies or procedures are developed.

• Manage and retain training logs for team members that are assigned training as completed.

• Assist in coordinating annual training. ‘

• Responsible for maintaining records of all pharmacy activities including but not limited to:

• Collection and review of BPRs

• Document daily monitor of temperature and humidity for pharmacy on a monthly/quarterly basis.

• Manage filing of SDS, equipment list, CAPAs, cleaning logs, and other documents record retention.

• Develop and maintain monthly logbooks pertaining to QA and Operations (e.g., Cleaning Checklists and Waste Logs).

• Provide support in the collection and documenting data trends.

• In collaboration with operations maintain equipment calibration records and monitor schedules.

• Monitor and document Monitor FDA weekly enforcement log on a monthly basis for any recalls that could impact raw 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.

• Assists in maintaining a safe work environment by assisting in safety programs, and by conducting safety audits (Hazards Training Program, Spill Kits, Eye Wash)

• Assist in conducting and documenting annual drills and staff demonstrations in hazardous training program.

• Conduct and document monthly RO pH testing.

• Coordinate and document monthly RO filter checks and cleaning.

• Coordinate processes to ensure that any rejected product is quarantined and removed from the receiving/affected location.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy Science, or a related scientific field is strongly preferred.

• 2+ years of experience in quality assurance, quality control, or regulatory compliance within a pharmacy, pharmaceutical manufacturing, or cGMP-regulated environment.

• Familiarity with pharmacy compounding regulations (e.g., USP <795>, <797>, or <800> guidelines) and state board of pharmacy standards.

• Exceptional precision and thoroughness when inspecting products, reviewing batch records, and maintaining documentation.

• Strong written and verbal communication skills with the ability to clearly document technical findings and collaborate effectively with pharmacy technicians and management.

Perks

• 100% company-paid Medical, Dental, and Vision premium coverage for employees, plus.

• Short-Term Disability and Life Insurance

• 401(k) with company match

• Complimentary daily lunch provided on-site