DSCSA Compliance Specialist

10 hours ago


Columbia, South Carolina, United States HTI Full time
Job Title: DSCSA Project Manager

PAI Pharma is seeking a highly skilled Project Manager to lead our DSCSA compliance efforts and drive process improvements in a production environment.

We are a leading manufacturer and distributor of high-quality, US-made liquid and unit dose prescription and OTC pharmaceuticals. With a robust R&D center and a rapidly growing workforce, we have launched 21 new products in 2024 alone and continue to invest over $18 million annually in research.

Key Responsibilities:
  • Manage customer DSCSA scorecards and issue trackers to ensure timely resolution of issues.
  • Develop and update processes for resolving DSCSA issues, ensuring unresolved issues are addressed within 3 days.
  • Provide weekly compliance reports to senior leadership and other stakeholders.
  • Collaborate with various business functions to review and correct reported issues.
  • Evaluate data flow and identify improvement projects to address problem areas.
  • Execute complex project implementation tasks across multiple projects and customers.
  • Engage with customers to identify and resolve track and trace issues.
  • Work with the DSCSA onboarding team and engineers to address repeat errors or technology issues.
  • Conduct workshops and meetings to highlight issues and brainstorm process improvements.
  • Review and update SOPs to reflect process changes for better compliance.
  • Determine training needs and conduct periodic refreshers for users affecting DSCSA data.
  • Participate in shipment process improvements and identify projects to reduce errors.
  • Lead cross-functional meetings on DSCSA issue resolution and customer reviews.
Requirements:
  • Bachelor's degree in Information Systems, Computer Science, or a related field, or an equivalent combination of education and experience.
  • Approximately 10 years of work experience, with 3-5 years in project management focused on issue resolution.
  • Experience in a production environment, with pharmaceutical experience being a significant plus due to knowledge of DSCSA, validation, and quality.
  • Knowledge and experience with ERP systems (production ERP preferred, SAP highly preferred).
  • Experience with serialization (GTIN, NDC, SSCC, etc.).
  • Technical experience working with software, XML knowledge, and EDI is a plus.
  • Ability to manage and track customer issues, gather resources, and drive improvements.
What We Offer:
  • Full benefits package – Medical, Dental, Vision, EAP, 401k Match
  • Onsite Wellness Center
  • Relocation Assistance
  • Tuition Reimbursement
  • 13 Paid Holidays + 1 Floating Holiday
  • Competitive PTO policy


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