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. The responsibilities may include the following tasks, knowledge, skills and other characteristics. (This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
- 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.
Qualifications: - 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, MasterControl, Trackwise, and ComplianceWire 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 (< 10%) desired.
- Position is minimum 75% on-site
- Subject to broad policy and management guidance regarding business goals.
- Leadership or controlling role on end results.
Location: Spokane, WA - On Site, Hybrid at least 75% onsiteShift: Monday-Friday 8:00AM-5:00PM
Compensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: $89,300.00 - $142,800.00, with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:- Medical, Dental & Vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D Insurance
- Short-Term & Long-Term Disability Insurance
- Employee Assistance Program
