Quality Assurance Specialist

Meds•Elmhurst, IL

56d•Onsite

About The Position

Meds.com is a consumer technology firm operating healthcare businesses, including BlueChew and MOD, and develops pharmacy, telemedicine, and e-commerce platforms. The Quality Assurance Specialist works onsite at the company’s Elmhurst, Illinois pharmacy facility to help maintain product safety, regulatory compliance, and operational quality across compounding and fulfillment processes. The role works directly on the pharmacy floor with pharmacy operations and the broader QA team, auditing processes, reviewing batch records, inspecting incoming materials, and ensuring adherence to SOPs and applicable state and federal regulations. The position also coordinates quality records and training, supports inspections and safety programs, maintains controlled documentation and operational logs, and assists with monitoring pharmacy equipment, materials, and environmental conditions. The role is full-time and onsite.

Requirements

At least 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, such as 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, including the ability to clearly document technical findings and collaborate effectively with pharmacy technicians and management.

Nice To Haves

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

Responsibilities

Serve as primary quality records coordinator and support the QA Manager with broader quality assurance initiatives.
Support the Quality lead during announced and unannounced inspections.
Support 5S goals to maintain a better organized, safer, cleaner, and more efficient workplace.
Support development, review, and updating of pharmacy policies, procedures, logs/forms, and training materials.
Maintain knowledge of current regulatory requirements pertaining to USP non-sterile compounding.
Manage the SOPs and Forms Control index.
Ensure policies and procedures comply 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.
Support onboarding of new hires by initiating training.
Support training management through quizzes and updates when policies or procedures are developed.
Manage and retain completed training logs for team members assigned training.
Assist in coordinating annual training.
Maintain records of pharmacy activities, including collection and review of BPRs.
Document daily pharmacy temperature and humidity monitoring on a monthly or quarterly basis.
Manage filing and retention of SDS, equipment lists, CAPAs, cleaning logs, and other documents.
Develop and maintain monthly QA and Operations logbooks, such as cleaning checklists and waste logs.
Support collection and documentation of data trends.
Work with operations to maintain equipment calibration records and monitor calibration schedules.
Monitor and document the FDA weekly enforcement log monthly for recalls that could affect received raw ingredients or materials.
Review and document Certificates of Analysis for products provided by contract manufacturers, and ensure they are properly stored.
Retain waste-disposal documentation.
Support workplace safety programs and conduct safety audits, including audits of the Hazards Training Program, spill kits, and eye wash equipment.
Assist with conducting and documenting annual drills and staff demonstrations for the hazardous training program.
Conduct and document monthly RO pH testing.
Coordinate and document monthly RO filter checks and cleaning.
Coordinate processes to ensure rejected product is quarantined and removed from the receiving or affected location.