Sr Associate Deviation Analyst
About The Position
This role is for a Deviation Analyst within the Quality Systems area. The ideal candidate will have a Bachelor's Degree with two years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills are required, along with Project Management skills. The position operates on an administrative shift, adaptable to business needs. Experience in deviation management within a GMP/GxP environment, including ownership of major and minor deviations and the full investigation lifecycle, is essential. Familiarity with computerized manufacturing systems such as MES, Veeva, SAP, PCS, or PI Historian is also required. The role emphasizes multitasking, scientific thinking, creativity, teamwork, ethical conduct, and the application of the scientific method in a competitive yet collaborative environment.
Requirements
- Bachelor's Degree
- Two (2) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Experience in Deviation management within a GMP/GxP environment, ownership of major and minor deviations.
- Experience in Investigation lifecycle from initiation through closure.
- Experience with Computerized manufacturing systems, including platforms such as MES, Veeva, SAP, PCS, or PI Historian.
Responsibilities
- Responsibility extends to multiple departments/functional areas.
- Demonstrates thorough knowledge of objectives and processes in multiple departments/functional areas supported.
- Promotes and develops communication between assigned business unit, technical staff, and vendors to integrate information systems.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations.
- Conducts impact analysis of new products, systems, upgrades, and changes for multiple departments/functional areas.
- Evaluates systems and business processes for feasibility in multiple departments/functional areas. Able to recognize problems and communicate.
- Establishes and maintains positive business relationships with managers and staff in multiple departments/functional areas.
- Has a thorough understanding of the client’s business, their processes, and their priorities.
- Ensures system functionality and performance meet current and future business requirements. May apply principles, theories and concepts.
- Prepares complex documentation for assigned projects.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
