• US Citizen

• Security Clearance

• Green Card

• EAD (OPT/CPT/GC/H4)

• W2-Contract

• 1099-Contract

• Contract to Hire

• Need H1B

• Consulting/Contract

• UG :- B.Tech - Not Required

• PG :-

• No of position :- ( )

• Post :- 21st Jun 2022

Position ID: DYESAB00024175

Title: Business Analyst with Pharma / Med Device Exp

Location: Waukegan, IL

Duration: 12 Months+

 

US Citizens, GC, H4 EAD only – C2H position

 

Locals only – Hybrid Remote (3days onsite / 2 days remote per week)

 

Job Description

Seeking a Sr. Business Systems Analyst to join the  Pharmaceutical client EPIQ Team. Be a part of a dynamic environment, delivering high value quality critical solutions to multiple  Pharmaceutical client MEDICAL DEVICE business units.

 

WHAT YOU’LL DO

·         Conduct business analysis and business process mapping with cross-functional teams to define requirements.

·         Facilitates requirement approval from Core team, GIT, Validation, and Business Process Owners.

·         Makes appropriate recommendations for continuing, modifying, or abandoning proposed projects based on the results of feasibility studies and/or cost/benefit analyses.

·         Own and drive software life cycle quality documentation

·         Confirm overall testing strategy and ensure on time test execution

·         Serve as subject matter expert on Complaint Management, Microbiology, Nonconforming Material Reporting (NCMR), Audit, Corrective Action Preventative Action (CAPA), Supplier Quality, EPIQ Access Control (EAS) and EPIQ Mobile Systems and provide troubleshooting of application issues

·         Participate in the analysis, design, and implementation of Product, Development, and Approval systems.

·         Serve as a technical representative for validation reviews and approvals.

·         Work closely with a project team and delivery manager to deliver solutions within the designated time, budget, and contractual expectations.

·         Serve as team subject matter expert for  Pharmaceutical client’s IT Standard Operating Procedures (SOPs) including but not limited to System Lifecycle (SLC), Cybersecurity, Data Lifecycle Management (DLM), disaster recovery, and data privacy.

·         Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

·         Review and provide feedback on work produced by BSAs from delivery partners.

·         Collaborate with & own relationships with global cross functional teams across 8-12 hours’ time zone difference.

·         Must stay focused on goals, and lead meetings/conversations to successful outputs

 

EDUCATION AND EXPERIENCE YOU’LL BRING

REQUIRED

·         Bachelor’s Degree

·         Minimum 4 years’ experience with business systems analysis

·         Experience with Software Lifecycle (SLC) methodologies

·         Experience with validated systems in a regulated environment

 

PREFERRED

·         Familiarity with project phases, deliverables, and leading vendor resources

·         Knowledge and experience with  Pharmaceutical client SLC or similar SOPS

·         Knowledge and experience with FDA and other competent authority regulations

·         Detail oriented with a proven ability to self-motivate and follow-through on tasks

·         Strong problem solving, analysis and communication skills, both verbal and written

·         Excellent communication and customer service skills.  Able to bridge communication between technical areas and business areas for a full and complete understanding of expectations

 

 

Thanks & Regard’s

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 701-5896 /© 224-635-0898