Investigation Specialist

Gifthealth Inc•Columbus, OH

1d•Onsite

About The Position

The Investigation Specialist is responsible for leading and supporting quality investigations within a regulated pharmacy operations environment. This role evaluates deviations, complaints, dispensing errors, process failures, documentation discrepancies, environmental monitoring events, and other quality or compliance events to determine root cause, assess risk, and drive effective corrective and preventive actions. The Investigation Specialist reports to the Manager, Dispensing Pharmacy Quality Assurance and works cross-functionally with Pharmacy Operations, Supply Chain, and other business partners to ensure investigations are thorough, timely, data-driven, and aligned with applicable regulations, company procedures, and industry expectations.

Requirements

Strong attention to detail and documentation discipline.
Objective, evidence-based decision-making.
Ability to distinguish symptoms from true root cause.
Strong collaboration with cross-functional operational teams.
High sense of urgency balanced with sound quality judgment.
Professional communication with internal stakeholders, clients, auditors, and regulators.
Ability to work independently in a fast-paced, regulated environment.
Commitment to patient safety, product quality, and compliance.
Strong business acumen required to be client facing.

Nice To Haves

Experience in specialty pharmacy, mail-order pharmacy, compounding pharmacy, pharmaceutical manufacturing, distribution, or 503A/503B operations.
Experience using electronic quality management systems such as Track Wise, Master Control, Veeva or similar platforms.
Familiarity with FDA 21 CFR Parts 210/211, USP, DSCSA, HIPAA, and applicable state pharmacy regulations.
Experience supporting audits, regulatory inspections, or client quality reviews.
Certification such as CQA, Six Sigma Yellow/Green Belt, RAC, or Lean certification.

Responsibilities

Conduct, document, and manage investigations related to deviations, nonconformances, complaints, medication dispensing events, process excursions, documentation errors, and quality events.
Perform impact assessments to determine potential effects on patient safety, product quality, regulatory compliance, and business operations.
Develop clear, objective investigation reports that include event summaries, timelines, evidence review, root cause analysis, risk assessment, conclusions, and CAPA recommendations.
Ensure investigations are completed within required timelines and meet internal quality standards.
Identify appropriate corrective and preventive actions to address confirmed root causes and reduce recurrence risk.
Partner with process owners to define CAPA plans, owners, due dates, effectiveness checks, and measurable success criteria.
Monitor CAPA completion and support effectiveness verification activities.
Support the administration and continuous improvement of quality systems, including deviations, complaints, CAPA, change control, training, documentation, and audit readiness.
Ensure investigation practices comply with applicable DEA, FDA, USP, Board of Pharmacy, and company requirements.
Maintain accurate, complete, and inspection-ready records in Dot Compliance.
Assist with internal audits, client audits, regulatory inspections, and inspection readiness activities, as needed.
Collaborate with pharmacy operations teams to understand workflows involving prescription intake, fulfillment, dispensing, verification, packaging, shipping, inventory control, and patient support activities.
Evaluate operational data, dispensing records, prescription documentation, system logs, call recordings, shipping data, and other evidence as part of investigations.
Identify recurring trends, process gaps, training needs, documentation weaknesses, or system issues that may contribute to quality events.
Recommend process improvements that strengthen compliance, reduce risk, and improve operational performance.
Support periodic trending of deviations, complaints, errors, CAPA, and other quality metrics.
Identify adverse trends and recurring issues requiring escalation, remediation, or management review.
Participate in quality councils, management review meetings, operational huddles, and continuous improvement initiatives.
Contribute to updates of SOPs, work instructions, forms, templates, and training materials based on investigation outcomes.