What are the responsibilities and job description for the DSCSA Analyst position at Sibitalent Corp?
Job Details
Job Title: DSCSA Analyst Location: Greenville, South Carolina- ONSITE (NEED LOCAL CANDIDATE) Duration: 6 months contract
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.
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 res 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.
KNOWLEDGE, SKILLS & ABILITIES:
This position requires the individual to be organized, detail-oriented, and self-motivated. Standard office equipment is used.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS:
The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be provided to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Periodic visits to cGMP manufacturing, packaging and warehouse areas.
