Pharmacy CAPA Coordinator

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The Pharmacy CAPA Coordinator will be responsible for managing and maintaining the Quality Management System (QMS) for KnippeRx, ensuring compliance with current client contractual requirements, accreditation standards, and all relevant pharmacy regulations. This role will focus on supporting Knipper Health’s Custom Pharmacy Solutions (CPS) business, which includes patient services, pharmacy operations, patient support services, and direct-to-patient fulfillment. The CAPA Coordinator will serve as a power user of Knipper Health’s electronic QMS (e-QMS) and Document Control systems (e-DMS), leading Corrective and Preventive Action (CAPA) initiatives, quality event investigations, and change control processes.

The individual will act as a quality partner across cross-functional teams including Hub Services, Client Services, Pharmacy Operations, Call Center, and Compliance to drive continuous improvement and operational excellence in line with Knipper Healh’s patient-first commitment.

• Oversee and maintain KnippeRx’s QMS processes including CAPA, deviations, quality events, and change control to ensure compliance with FDA, state boards of pharmacy, and client requirements.
• Serve as a subject matter expert (SME) and administrator of KnippeRx’s e-QMS and e-DMS platforms.
• Review, approve, and monitor investigations, CAPA plans, effectiveness checks, and change requests to ensure quality risks are appropriately mitigated.
• Advise department leaders on their development and update of department Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Support the establishment of client Quality Agreements for KnippeRx pharmacy operations.
• Support all internal and external audits, including regulatory inspections, client audits, and internal quality reviews.
• Partner with Pharmacy Operations and Hub Services teams to conduct root cause analysis (5 Whys, Ishikawa, fault tree analysis) and implement preventive measures for recurring issues.
• Generate and analyze QMS performance data, issuing regular quality reports for leadership, including trending of quality events and audit findings.
• Lead initiatives with Operational Excellence team to enhance workflow automation and optimize e-QMS configurations to improve efficiency and reduce manual errors.
• Promote a quality culture within KnippeRx by mentoring employees on compliance best practices, risk management, and continuous improvement.

The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS:

• Bachelor’s Degree, and/or equivalent combination of education and experience
• 3 – 5 years of Quality Systems experience in a regulated environment. Experience in Pharmacy Operations, Pharmacy Fulfillment, and Call Center is preferred.

• Strong knowledge of CAPA, deviation management, and root cause analysis methodologies.

• Relevant ASQ or RAPS certifications are preferred but not required.
• Ability to analyze data and present data.
• Ability to work independently and in a team environment
• Excellent communication skills (verbal and written) and customer service.
• Ability to prioritize multiple tasks and accomplish them in a timely manner.

KNOWLEDGE, SKILLS & ABILITIES:

• Proficient in Microsoft Office applications. WORD Level – basic skills required; EXCEL – Intermediate Level required.
• Experience utilizing e-QMS, ERP, and data center programs like/TrackWise Digital, SharePoint, and Microsoft Dynamics.
• Strong knowledge of CAPA system requirements and Root Cause Analysis tools
• Ability to maintain the highest level of confidentiality.

• Strong understanding of Quality System requirements including relevant USP <800> standards, state board of pharmacy regulations, NABP, URAC or ACHC accreditation standards, HIPAA/HITECH requirements, and best practices for hub services and patient support programs. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or business community members.
• Ability to effectively present information to top management, public groups, and members of senior management.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write technical reports, business correspondence, and procedure manuals.

PHYSICAL DEMANDS:

• Location of job activities 100% inside
• Extensive manual dexterity (keyboarding, mouse, phone)
• Use of phone for communication
• Noise and/or vibrations exposure
• Frequently reach (overhead), handle, and feel with hands and arms
• Sit for prolonged periods of time
• Occasionally stoop, kneel, and crouch
• Occasionally lift, carry, and move up to 25 pounds

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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