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 ResponsibilitiesCoordinate and maintain quality system activities across pharmacy and telehealth workflowsRecord and track deviations, CAPAs, change controls, and quality incident notifications (QINs)Act as a first-line quality contact for staff and escalate issues to managementDraft, revise, and maintain SOPs, forms, and quality recordsReview COAs, batch records, and compounding logs for complianceSupport verification of potency, sterility, and stability testing resultsPrepare documentation for internal and external audits, inspections, and accreditation reviewsProvide quality training and develop competency-based onboarding/refresher programsCompile quality metrics (deviations, audit findings, complaints) and prepare leadership reportsSupport vendor qualification and track costs related to testing, deviations, and product reworkRequired QualificationsBachelor’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 environmentKnowledge of USP , , , , FDA 21 CFR Parts 210/211, DEA, DSCSA, HIPAA, and state board requirementsStrong organizational, documentation, and communication skillsExperience with sterile and non-sterile compounding QA/QCWorking knowledge of QMS software systems; eQMS/EHRs/pharmacy management systems a plusProficiency with Google Workspace (Docs, Sheets, Slides)Core CompetenciesAttention to detail and strong documentation skillsAnalytical and problem-solving abilityEffective written and verbal communicationAbility to work independently and collaboratively across teamsCommitment to patient safety, compliance, and continuous improvementCompensation & BenefitsSalary: $85,000 – $95,000 annually (commensurate with experience)Health, dental, and vision insuranceEmployee Stock Ownership Plan (ESOP)401(k) with company matchPaid time off and holidaysProfessional development reimbursementSchedule:Full-time8 hour shiftMonday - FridayWork Location:In person, Bellmore / Farmingdale, NY (required)Must be able to commute or relocate before starting workAs 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 mypcphealth.com.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.