Quality Compliance Specialist, Post Market Surveillance

Stellenbeschreibung:

Manage intake, investigation, and resolution of customer and partner complaints related to prescription products
Independently investigate, document, and communicate complaints to customers and relevant stakeholders
Review complaint details for accuracy, including order IDs and pharmacy/compounder attribution
Triage and route complaints to appropriate third parties based on complaint description and location
Evaluate third-party pharmacy investigations and assess root cause analysis adequacy
Require re-investigation when findings do not meet quality standards
Determine regulatory reportability under 503A/503B classifications and applicable FDA reporting requirements
Hold third-party pharmacies accountable for complaint closure summaries and investigation reports
Track contractual and regulatory deadlines and elevate at-risk cases proactively
Identify and analyze complaint trends across categories such as packaging, cold chain, and dosage
Recommend process changes based on complaint trend findings
Create regular metric reports for senior leadership covering complaint trends, root cause analysis, and action plans
Organize and lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, medical affairs, supplier, and strategic quality teams
Review and concur on third-party complaint investigation findings
Determine complaint investigation outcomes without case-by-case approval from the Director
Use pharmacy expertise to influence workflow changes and product improvements

Requirements

Preferably work in the EST time zone
Active Pharmacy Technician or Pharmacist license preferred
Bachelor’s degree in a relevant science, quality, or engineering field preferred; or an associate degree with equivalent experience will be considered
4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment
Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements
Knowledge of 21 CFR Parts 210/211, cGMP, and GDP practices
Understanding of USP <795> and <800> standards and non-sterile compounding processes
Strong oral and written communication skills
Experience with complaint or case management platforms such as Zendesk
Ability to manage multiple open investigations simultaneously while maintaining documentation accuracy
Excellent analytical skills to identify trends and root causes across complaint data
Ability to manage multiple tasks and meet deadlines in a fast-paced, remote-friendly healthcare environment
High sense of accountability and a collaborative, team-oriented mindset
Commitment to patient safety and rigorous quality standards
Pharmacy expertise to influence workflow changes and product improvements related to customer safety and satisfaction

Core Competencies

Demonstrates expertise in complaint management and resolution within pharmacy operations, ensuring compliance with regulatory standards such as 503A/503B and FDA requirements. Proficient in analyzing complaint trends and leading cross-functional teams to enhance product quality and customer satisfaction.