What are the responsibilities and job description for the Data Specialist position at Sibitalent Corp?
Title: DSCSA Analyst
Location: Greenville, South Carolina- ONSITE (NEED LOCAL CANDIDATE)
Description:-
Must-Have Qualifications:
✔ 3-5 years of experience as a Data Analyst with serialization expertise (DSCSA experience preferred, not a must-have).
✔ 1-2 years of experience in pharmaceutical manufacturing or SAP (Production Planning, Operations, Quality, Warehouse, Master Data, Sales & Distribution).
✔ 3-5 years of hands-on experience in pharmaceutical packaging or a similar package process and manufacturing, including serialization, aggregation, validation (IQ/OQ/PQ), and FDA/cGMP compliance.
Pluses:
• Prior DSCSA compliance experience.
• Six Sigma certification and process improvement expertise.
DSCSA analyst is responsible for reviewing how PAI functions conduct activities in handling serialized products, in compliance with internal policies /procedures, that affect DSCSA data integrity.
The Analyst must work with one or more functions and create weekly reports on observations, that can be leveraged for improving the processes at PAI. The role is onsite, based in Greenville, SC.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. The main responsibilities are to measure compliance in handling serialized products, and help to improve processes through training, procedures, and feedback.
2. Work with PM – DSCSA to track customer DSCSA scorecards and internal DSCSA issues
3. Create / maintain a process to conduct audits with a checklist of issues
4. Create / update a tracker to document issues, in which a process was not adhered to
5. Conduct joint meetings with department and VP of IT, to confirm the findings with the department
6. Work with the department in creating an action plan for repeat issues
7. Provide weekly report to PM-DSCSA and VP of IT
8. Make recommendations on processes and technology that will help to identify and eliminate DSCSA issues
9. Identify time consuming mistakes, and identify how different functions can improve their process to minimize the effort spent in corrections
10. Ensure that processes and process updates are reflected in SOPs of the related functions
11. Determine training needs and conduct periodic refreshers to help users who impact DSCSA data
12. Partner with other IT resources on integration with serialization, EDI, contracts software, quality systems, and other systems to consider technology options that support this role.
13. Perform other duties as assigned.
EDUCATION AND/OR EXPERIENCE:
A bachelor’s degree in information systems or computer science field(s) and 5 years of work experience. Or an equivalent combination of education and experience. Experience in working in warehouses, shop floor (production), quality control is highly desirable. Desirable experience of 1-2 years of experience in pharmaceuticals, and 1-2 years of SAP experience (using one or more modules in operations, quality, warehouse, master data, sales and distribution). Knowledge of IT systems, Six Sigma tools, root cause analysis and process improvement methodologies is desirable.
