Coordinator- Pharmacy Operations & Regulatory Affairs at Knipper HEALTH

, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacy Operations, Quality Compliance, SOP Implementation, Accreditation Readiness, Cross-Functional Leadership, Operational Optimization, Documentation Management, Training Development, Controlled Substance Management, Project Management, Problem Solving, Data Analysis, Communication Skills, Regulatory Knowledge, Workflow Validation, Client Services

Industry

Pharmaceutical Manufacturing

Description

Overview YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the Caretria Team! POSITION SUMMARY The Coordinator, Pharmacy Operations & Regulatory Affairs is a pharmacist leader responsible for building and sustaining a high-reliability operating model for our Lakeland pharmacy. This role partners closely with the Director of Pharmacy, fulfillment leaders, Quality, Compliance, and Technology to strengthen operational governance, SOPs, accreditation readiness, controlled substance program safeguards, and new program launch execution. This position is designed for an execution-oriented leader who can translate “what good looks like” into practical workflows, documentation, training, and measurable outcomes—while driving cross-functional projects that continuously improve quality, compliance, productivity, and scalability. Onsite - KEP / Hybrid per Business Needs Responsibilities KEY RESPONSIBILITIES: 1) Operational Optimization & Best Practices Own and maintain the site-level Operating Standards for pharmacy practice and fulfillment execution (e.g., floor practices, controls, handoffs, error mitigation). Lead structured problem-solving for operational friction points (root cause, corrective action, prevention plans), partnering with fulfillment leadership to ensure adoption. Partner with Quality and Investigation/Reporting teams to define, monitor, and interpret key indicators of quality, compliance, and inspection readiness (e.g., SOP adherence, deviations, audit findings, CAPA timeliness/aging, training completion), ensuring trends and insights are communicated to site leadership for action. Drive productivity improvements and maintain a KPI cadence for throughput, labor efficiency, cycle time, and backlog/aging; translate performance gaps into actionable improvement plans. Support Client Services by providing timely operational information and fulfillment metrics (e.g., SLAs, turnaround times, backlog status, error/rework drivers), and by partnering with Operations/Quality to investigate and help resolve client concerns related to fulfillment performance and patient experience. 2) SOP Governance, Documentation & Training Build and manage the SOP lifecycle: authoring, initial review, implementation, and periodic review. Ensure SOPs are operationally “usable” (clear roles/responsibilities, stepwise procedures, forms/templates, escalation pathways). Coordinate training content and rollout for new/updated SOPs; validate competency where needed (pharmacists, technicians, support teams). 3) Quality, Accreditation & Inspection Readiness Serve as a primary site SME for accreditation maintenance and readiness (e.g., NABP/URAC/ACHC as applicable), including evidence management and audit response coordination. Partner with Quality to manage deviations, investigations, CAPAs, change control, and internal audit schedules. Maintain a constant state of inspection readiness: mock BOP inspections, walkthroughs, documentation hygiene, and readiness “drills.” 4) Controlled Substance Program Development & Management Partner with Compliance leadership to design and operationalize, and maintain controlled substance workflows (receiving, storage, perpetual inventory, dispensing controls, reconciliation, discrepancy management, reporting, and monitoring). Draft/maintain SOPs, logs, and training associated with controlled substance handling; support readiness for DEA/BOP expectations. Support controlled substance program scaling (new products, new workflows, increased volume) with disciplined change control and validation. 5) Program Buildout & Launch Support (Including White-Label / Client Programs) Act as the site project resource for operational readiness for new programs: requirements translation, process mapping, SOPs, training, go-live checklists, and stabilization monitoring. Coordinate across Operations, Client/Program teams, Quality, Compliance, and Technology to ensure launches meet safety, compliance, and service expectations. Support white-label pharmacy models by ensuring consistent core practices while accommodating program-specific requirements in a controlled, documented way. 6) PMS, Automation, & Workflow Validation Support deployment and ongoing optimization of automation workflows from an operations excellence lens (SOPs, training, exception handling, controls, and performance monitoring). Participate in workflow validation/UAT as needed, with emphasis on operational controls, safety, and compliance impacts. 7) Cross-Functional Leadership & Communication Facilitate cross-functional working sessions and recurring governance (readiness reviews, CAPA reviews, SOP councils). Produce executive-ready updates: clear status, risks, decisions needed, and next steps. Influence without authority—driving adoption and sustained behavior change at the line level. The above duties are meant to be representative of the position and not all-inclusive. Qualifications Required Qualifications PharmD (or equivalent) and active pharmacist license in good standing; ability to obtain/maintain additional licenses as needed. 5+ years of experience in pharmacy operations, quality/compliance, fulfillment, specialty, mail order, or other regulated high-throughput environments. Demonstrated success leading cross-functional initiatives: SOP implementation, accreditation readiness, inspection preparedness, CAPA/change control, or operational transformation. Strong executive presence and ability to communicate clearly with frontline staff through senior leadership. Highly organized with strong documentation practices and operational rigor. Preferred Qualifications Experience supporting accreditation programs (e.g., URAC, NABP) and responding to audits/inspections. Exposure to controlled substance program development and/or high-accountability inventory controls. Experience in multi-site or multi-state pharmacy environments Familiarity with fulfillment automation environments and operational validation approaches. Prior PIC, delegated PIC, or formal leadership responsibility in regulated pharmacy operations. Knowledge, Skills & Abilities Operational excellence mindset: standard work, visual management, practical controls, and sustainable adoption. Strong writing and editing skills (SOPs, work instructions, training materials). Investigative rigor: root cause analysis, CAPA quality, and prevention-oriented thinking. Ability to translate regulatory requirements into workable, efficient workflows. Comfortable operating in ambiguity and building structure where none exists. Physical Demands Location of job activities 100% inside Noise and/or vibration exposure Stand and sit for prolonged periods of time Occasional bending or stooping Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 25 pounds. Occasionally lift and/or move objects up to 50 pounds Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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Responsibilities

The Coordinator is responsible for building and sustaining a high-reliability operating model for the pharmacy, focusing on operational governance, SOPs, and compliance. This role involves driving cross-functional projects to improve quality, compliance, productivity, and scalability.