DSCSA Compliance Analyst
Apply NowCompany: HTI
Location: Greenville, SC 29615
Description:
HTI is seeking DSCSA Compliance Analyst for PAI Pharma, a large manufacturer of prescription and OTC pharmaceuticals. Leveraging cutting-edge technology to produce the best-in-class suspensions and oral solutions, this manufacturer has been recognized for being a leader in innovation, quality, and safety. Understanding it is their employees who make the true impact, this organization is known for their commitment to being an employer of choice - offering competitive pay, benefits, and a positive environment for employees at any level!
What They Offer:
What Your Role Will Look Like:
The DSCSA Compliance Analyst is responsible for reviewing how PAI functions in conducting activities in handling sterilized products, in compliance with internal policies and procedures that affect DSCSA integrity. The main responsibilities are to measure compliance in handling serialized products, and help to improve processes through training, procedures, and feedback.
INDPRO
What They Offer:
- Full benefits package - Medical, Dental, Vision, EAP, 401k Match
- Onsite Wellness Center
- Tuition Reimbursement
- 13 Paid Holidays
- Progressive PTO Plan
- Bachelor's Degree in Information Systems or Computer Science Field
- 5+ years of experience in a similar role.
- 2+ years working in pharmaceuticals
- 2+ years working with SAP
What Your Role Will Look Like:
The DSCSA Compliance Analyst is responsible for reviewing how PAI functions in conducting activities in handling sterilized products, in compliance with internal policies and procedures that affect DSCSA integrity. The main responsibilities are to measure compliance in handling serialized products, and help to improve processes through training, procedures, and feedback.
- Ensure Compliance: Monitor and measure adherence to serialized product handling and internal policies.
- Track and Report: Work with the PM-DSCSA to track DSCSA scorecards, internal issues, and provide weekly reports to PM-DSCSA and VP of IT.
- Audit and Documentation: Create and maintain audit processes and checklists; document and track compliance issues.
- Issue Resolution: Conduct joint meetings with departments and VP of IT to confirm findings; develop and implement action plans for recurring issues.
- Process Improvement: Recommend and implement process and technology improvements; address time-consuming mistakes and suggest enhancements.
- Training and SOPs: Determine training needs; conduct periodic training; ensure process updates are reflected in SOPs.
- Technology Integration: Collaborate with IT on integration with serialization, EDI, contracts software, and other systems.
INDPRO