Quality Assurance Manager

Overview

Meds.comis a rapidly growing consumer technology firmoperatinga suite of healthcare businesses, including our flagship brandBlueChew. Our mission is to better patients' lives through innovative healthcare solutions. With a team of 350 professionals across various specialties,we'vebuilt scalable pharmacy, telemedicine, and e-commerce platforms usingcutting-edgetechnology. As we continue our accelerated growth trajectory,we'relaunching new products to expand our patient base and accelerate growth. Join us in tackling exciting challenges at the intersection of healthcare and technology.

We areseekingan experienced, detail-orientedQuality Assurance Managerto lead and elevate the QA operations at our compounding pharmacy facility. In this role, you will directly manage a team of Quality AssuranceSpecialists, driving rigorous compliance, process validation, and quality control standards across all pharmacy operations.

As our QAManager, you will serve as the bridge between regulatory requirements, operational efficiency, and safety.You’llbe responsible formaintainingourhigh standardsfor cGMP/GADP compliance, overseeing batch record reviews, investigating deviations, and building a culture of continuous improvement across our team.

Join our team in Elmhurst, IL -we'relooking for someone who truly values and enjoys working onsite, not just tolerates it.

Responsibilities

As a QA Manager, you willbe responsible forquality-related activities at the facility associated with inspections, in-process and finished products, 3rd party testing, patient complaints, product investigations, and Corrective and Preventive Action (CAPA) plans.

• Lead announced and unannounced inspections.

• Oversee quality associate roles and responsibilities

• Oversee quality aspects of multi-site functions

• Assistinidentifyingpotential quality risks and working with operations personnel to develop improvement opportunities

• Supports the development of in-processverifications arein place to ensure product weights, correct labeling & packaging, and monitors when applicable.

• Recommend and implement improvements in streamlining processes and procedures in the areas of compounding, change control, and documentation.

• Support Quality leadership in conducting strategic assessments (i.e.gap analysis) of quality metrics.

• Drive quality improvements.

• Oversee day-to-day activities related to environmental monitoring,preparationrelease testing, and contamination control.

• Assistinidentifyingand conducting quality-related events and work with applicable personnel to achieve goals.

• Assistsin monitoring patient complaints and product investigations and documentation, helping to assess risk,identifyroot cause, and quarantine product.

• Conduct root cause analysis for audit observations, documentation, complaints, non-conformances, and in-process deviations with business partners.

• Executes action plans for product quarantine, destruction, rework, withdrawal/recall

• Reviews 3rd party testing laboratory results, as necessary

• Verify that raw materials COA meet specifications limits.

• Manages batch documentation, log records, test results, and good documentation practices

• Ensure maintenance of all required recordkeeping logs; visitor log, waste log,

• Ensure all product Active ingredient COA have been signed and filed for recordkeeping purposes

• SupportComplianceManager to maintain and run audits and reconciliations of records.

• Performs reviews and audits as assigned

• Manages safety programs and conducts safety audits as applicable. (Hazards Training Program, Spill Kits, Eye Wash)

• Provide technicalassistanceand guidance in areas of contamination control, environmental monitoring, and facility controls.

• Train,developand lead the quality team in support of the quality management system.

• Manages onboarding new hires byinitiatingtraining.

• Responsible for the delivery of site yearly training activities and training for site Quality Systems

• Coordinate curriculum management and proactivelyidentifyroles within the organization that areimpactedby changes to ensure colleagues are assigned theappropriate trainingincluding new hire training and ensure training compliance.

• Knowledgeable of current USP 795 regulations in collaboration with Compliance.

• Consult with managers in various groups to developan appropriate curriculum.

• Develop, review, and execute SOPs, protocols, and reports related to pharmacy operations.

• Review routine change control requests

• Assistwith:

• Managing and Maintain all SOPs, forms, and policies.

• Revising policies/SOPs to the extent that operations/procedures have changed.

• Under the direction of the compliancedepartmentrevising policies withanticipatedchanges in regulatory requirements.

• Participates in handling regulatory inspections in concert with pharmacy

• Manage inspection readinessprogramand activities for the site, ensuring an inspection-ready state.