Sr Specialist - QA DI & CSV

Job Description

Reporting to the QA Data Integrity Supervisor, the Quality Computer Systems Validation (QCSV) Senior Associate will provide Quality unit oversight related to qualification, GxP validation and change management of JHS computer systems. This position will oversee and support Software Validation activities for the Spokane, WA facility.

• Provide technical expertise to define approaches and execution of computer system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, and other applicable regulations or procedures.
• Work with IT CSV and Engineering to develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and review and approve functionality, usability and testing during required project phases.
• Review and enforce necessary improvements and corrections to established systems and processes via mitigation plans and change control.
• Work with project teams to select methods and techniques for obtaining desirable solutions for each project and ensure compliance with regulations.
• Direct the site Data Integrity program.
• Provide QA oversight of CSV Periodic Review program.
• Participate as SME in internal and external vendor audits relating to computerized systems.
• Keep appraised of the developments in all Jubilant Life Sciences' marketplace, and the challenges in the Business Units to identify potential opportunities.

• Bachelor's Degree in Computer Information Systems, Management Information Systems or related field required.
• Minimum of 5 years related experience in Computer System Validation required (with Bachelor's degree).
• 10+ years of experience can be used in lieu of a Bachelor's degree.
• FDA Regulated Industry experience required.
• Basic exchange of information required. Managing conflict and influencing outcomes required. Must possess excellent communication skills and have the ability to effectively interpret needs and requirements at the business process level as well as at the technical level required.
• Critical problem solving skills required.
• Must possess strong analytical experience and ability to work independently on concurrent assignments required.
• Advanced Vocational/Specialized Knowledge required. Microsoft Word, Excel and PowerPoint required.
• SAP, Master Control, Trackwise, and Compliance Wire desired.
• Supervisory experience desired.
• Pharmaceutical experience desired.
• Other
  
  Physical Requirements:
  
  Ability to lift 20 pounds unassisted.
• Prolonged sitting.
• Computer use, including keyboard and monitor.
• Ambiguous and complex situations: development of new solutions.
• Minimal travel (