Director of Quality Assurance and Compliance Position Available In Nassau, New York

Director of Quality Assurance and Compliance Precision Compounding Pharmacy 2657 Merrick Road, Bellmore, NY 11710

Job Title:

Director of Quality Assurance Location:

Bellmore/ Farmingdale NY Department:

Compliance Reports To:

VP of Compliance Industry:

503A Compounding Pharmacy (Telehealth Fulfillment)

Position Summary:

We are seeking a highly detail-oriented and compliance-driven Quality Assurance (QA) Manager to support our 503A compounding pharmacy operations with a focus on telehealth fulfillment. The QA Manager will play a key role in ensuring all compounded preparations meet federal and state regulations, internal quality standards, and USP , , and compliance requirements. This role is critical to ensuring patient safety, operational efficiency, and alignment with telehealth-driven dispensing workflows. The team member will also be tasked with building a quality team for Precision’s New York, Florida and California Locations.

Key Responsibilities:

Quality Systems Oversight:

○ Maintain and update SOPs related to compounding, packaging, labeling, and shipping. ○ Build processes to conduct Adverse Drug Event (ADE) and Quality Related Event (QRE) data and conduct Root Cause Analysis (RCA) with the operations team. ○ Trend quality data for preventative actions, workflow efficiency updates, etc. ○ Support ongoing compliance with USP , , , and

FDA 503A

guidance. ○ Conduct internal audits, investigations, and CAPA tracking.

Batch & Product Review:

○ Review compounding records and batch records for completeness and accuracy. ○ Ensure appropriate QA/QC testing is conducted in accordance with SOPs and applicable USP chapters and is properly documented.

Team Building :

○ Validate processes tied to prescriptions fulfillment before bringing on a team. ○ Build a robust QA/QC program ○ Recruit associates in New York, Florida, and California to carry out RCA initiatives at the ground level within two quarters.

Complaint & Deviation Handling:

○ Investigate quality complaints, deviations, and out-of-spec results. ○ Lead root cause analysis with applicable supervisors/managers and recommend corrective/preventive actions.

Training & Compliance:

○ Build a robust QA/QC training program for all applicable staff ○ Assist with onboarding and training of compounding and fulfillment staff on QA/QC procedures. ○ Ensure team compliance with pharmacy board and DEA requirements.

Continuous KPI Improvement:

○ Reduction in company wild quality related events (QRE) via tracking. ○ Increase in preventative action initiatives

Required Qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related science field.
• Minimum 5 years QA/QC experience
• Strong knowledge of USP , , , and 503A compounding regulations.
• Excellent documentation, organizational, and communication skills.
• Working knowledge of QA software systems.

Preferred Qualifications:

• Experience with sterile and non-sterile compounding QA.
• Familiarity with

DEA, HIPAA

, and multi-state pharmacy compliance.

• Experience working with telehealth platforms or virtual patient intake systems.

Work Environment & Conditions:

• Fast-paced compounding pharmacy with remote and direct-to-patient fulfillment.
• Compliance-focused environment with stringent documentation and inspection readiness.
• May require occasional travel or on-site presence for audits, inspections, or training.

Compensation & Benefits:

• Salary 120k-130k
• Health, dental, and vision insurance
• ESOP
• 401(k) with company match
• Paid time off and holidays Professional development reimbursement As part of Precision Compounding Pharmacy , 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! For more information, visit https://mypcphealth.com/ Precision Compounding Pharmacy 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. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. 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 jobs@mypcphealth.com to request accommodation.

Job Type:

Full-time Pay:

$120,000.00 – $130,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Schedule:

8 hour shift Monday to Friday Ability to

Commute:

Bellmore, NY 11710 (Required) Ability to

Relocate:

Bellmore, NY 11710: Relocate before starting work (Required)

Work Location:

In person