Quality Assurance Specialist

At Precision Medicine, we are revolutionizing healthcare! Our mission is to empower the evolution of modern medicine by providing accessible, personalized, and efficient healthcare solutions. Join our dynamic team where your expertise matters, your ideas are valued, and your background helps shape the future of patient care. We celebrate diverse perspectives and foster an environment where you can thrive, innovate, and make a meaningful impact on patients’ lives.

 

Job Summary

The Quality Assurance Specialist is responsible for daily activities that uphold high-quality standards across sterile and non-sterile compounding, ensuring compliance with federal, state, and local regulations, including FDA 21 CFR Parts 210, 211, and 820, USP <795>, USP <797>, USP <800>, USP <1163>, DSCSA, and HIPAA. This role monitors quality events, prepares reports, supports audits and inspections, delivers training, and drives continuous improvement.

 

Key Responsibilities

• Coordinate and maintain quality system activities across pharmacy and telehealth workflows
• Record and track deviations, CAPAs, change controls, and quality incident notifications
• Act as a first-line quality contact for staff and escalate issues to management
• Draft, revise, and maintain SOPs, forms, and quality records
• Review COAs, batch records, and compounding logs for compliance
• Support verification of potency, sterility, and stability testing results
• Prepare documentation for internal and external audits, inspections, and accreditation reviews
• Provide quality training and develop competency-based onboarding and refresher programs
• Compile quality metrics, including deviations, audit findings, and complaints, and prepare leadership reports
• Support vendor qualification and track costs related to testing, deviations, and product rework

 

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field preferred, or equivalent experience considered
• 2 to 4 years of quality, compliance, or regulatory experience in a pharmaceutical, compounding, or healthcare environment
• Knowledge of USP <795>, USP <797>, USP <800>, USP <1163>, FDA 21 CFR Parts 210, 211, and 820, DEA, DSCSA, HIPAA, and state board requirements
• Strong organizational, documentation, and communication skills
• Experience with sterile and non-sterile compounding QA/QC
• Working knowledge of QMS software systems, eQMS, EHRs, and pharmacy management systems is a plus
• Proficiency with Google Workspace, including Docs, Sheets, and Slides

 

Preferred Qualifications

• Strong attention to detail and documentation skills
• Analytical and problem-solving ability
• Effective written and verbal communication
• Ability to work independently and collaboratively across teams
• Commitment to patient safety, compliance, and continuous improvement

 

Salary

$85,000 - $95,000 annually

 

Benefits

• 401(k)
• 401(k) matching
• Health insurance
• Dental insurance
• Vision insurance
• Paid time off
• Employee Stock Ownership Plan (ESOP)

 

Schedule

• Monday - Friday
• 9:00 AM - 5:00 PM

 

Work Location

• Onsite
• Boca Raton, FL

 

Why Join Us

As part of Precision Medicine, you’ll be at the heart of an exciting transformation in the telemedicine landscape. Together, we’re pioneering solutions that bridge technology and compassionate care, improving health outcomes for all. We’re committed to your growth, providing you with the resources and support you need to build a meaningful career while exploring your creativity. Ready to be a part of something groundbreaking? Join us as we move healthcare forward, one innovation at a time!

 

Learn more at: https://mypcphealth.com/

 

Equal Opportunity Statement

Precision Medicine is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve. The EEO posters are available here. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at talentacquisition@mypcphealth.com to request accommodation.