Quality Specialist

At Precision Medicine, we’re not just redefining healthcare; we’re revolutionizing it! With a mission to empower the evolution of modern medicine, we are dedicated to shaping a future where healthcare is accessible, personalized, and efficient. Join a vibrant team where your voice matters, your ideas are valued, and your unique background enriches our culture. We celebrate diverse perspectives and foster an environment where you can thrive, innovate, and make a real impact in the lives of patients.

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 (FDA 21 CFR Parts 210/211/820, USP , USP, USP, , DSCSA, 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 (QINs)
• 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/refresher programs
• Compile quality metrics (deviations, audit findings, 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 related field preferred (equivalent experience considered)
• 2–4 years of quality, compliance, or regulatory experience in pharmaceutical, compounding, or healthcare environment
• Knowledge of USP , , , , FDA 21 CFR Parts 210/211, 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/pharmacy management systems a plus
• Proficiency with Google Workspace (Docs, Sheets, Slides)

Core Competencies

• Attention to detail and strong 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

Compensation & Benefits

• Salary: $85,000 – $95,000 annually (commensurate with experience)
• Health, dental, and vision insurance
• Employee Stock Ownership Plan (ESOP)
• 401(k) with company match
• Paid time off and holidays
• Professional development reimbursement

Schedule:

• Full-time
• 8 hour shift
• Monday - Friday

Work Location:

• In person, Bellmore / Farmingdale, NY (required)
• Must be able to commute or relocate before starting work

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

For more information, visit .

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 unique perspectives it brings to our workforce and community.

We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application or interview process, to perform essential job functions, and to receive other benefits of employment. Please contact us at to request accommodations.