Investigation Specialist

Description

About Us

At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives.

Position Summary

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.

Key Responsibilities

Investigation Management

• 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.

Root Cause Analysis and CAPA

• 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.

Quality Systems and Compliance

• 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.

Pharmacy Operations Support

• 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.

Trending and Continuous Improvement

• 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.

Qualifications

• 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.

Skills:

• 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.

Work Environment

• Location: On-site
• Schedule: Full-time
• May require additional availability or flexibility for escalations.
• Regular meetings with your teams, departments, or leadership to ensure alignment.

Key Essential Functions

• Ability to work in an office, pharmacy, warehouse, production, or controlled operations environment as required.
• May require occasional standing, walking, or observation of operational processes.
• May require review of confidential patient, prescription, quality, or business records.
• Must follow applicable safety, security, gowning, and access control requirements.

Employment Classification

Status: Full-time
FLSA: Exempt

Equal Employment Opportunity (EEO) Statement

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.

We celebrate diversity and are committed to creating an inclusive environment for all employees. If you do not meet every requirement but still feel you would be a great fit for this role, we encourage you to apply!

Disclaimer

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.