IT Quality Assurance Analyst assists in the evaluation, testing, and validation of IT systems, services and /or software. Assesses service levels and product performance to ensure they meet established quality standards. Being an IT Quality Assurance Analyst documents issues and tracks status in designated systems. Develops or participates in the development of solutions to resolve problems. Additionally, IT Quality Assurance Analyst requires a bachelor's degree in IT or related field. Typically reports to a manager. The IT Quality Assurance Analyst work is closely managed. Works on projects/matters of limited complexity in a support role. To be an IT Quality Assurance Analyst typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Duties/Responsibilities | |
1 | Performs ‘Quality on the Floor’ duties, including supporting Manufacturing during production by providing guidance regarding established procedures and processes, participates in room and equipment clearances and other quality checks required during the manufacturing and packaging processes. |
2 | Perform review and release of all executed Manufacturing Batch Records and supporting documentation for completeness, accuracy, and compliance. |
3 | Review and approve test results from analytical laboratories and disposition raw materials and finished products. |
4 | Perform initial triage of deviations that occur during batch manufacture or packaging, demonstrating the ability to understand complex quality issues. |
5 | Participate in Cross-functional Root Cause Analysis meetings. |
6 | Provide quality oversight, document review and guidance for other departments. |
7 | Author/Review Standard Operating Procedures and other quality related GMP documents. |
8 | Models effective and constructive communication behaviors and interactions with all departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skills. |
9 | Assists with the development of CAPA and collaborates with stakeholders to ensure all necessary activities are executed timely and effectively. |
10 | Escalates critical events and investigation findings to Management. |
11 | Assist in developing and maintaining various quality systems and programs. May also represent the Quality Assurance group on various project teams such as validation, engineering phase review meetings, and daily department communication meetings. |
12 | Requires interaction with Manufacturing Operations, Operations Engineering, QA Management, Quality Control, Regulatory Affairs, EHS, IT, and Pharmaceutical Development and Technical Services. |
13 | Other duties as assigned. |
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
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