QA Change Control

Job Title: QA Change Control

Job Location: Sanford, NC

Job Type: Contract

Role Summary

This position supports the Pharmaceutical Sanford, NC Quality Assurance department by performing Quality Assurance activities related to change control and validation associated with clinical and commercial products. Colleagues in this role should be able to demonstrate the following:

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) and Pharmaceutical Quality Standards to be a key contributor
• Contribute to the interpretation of cGMPs for commercial and clinical product
• Independently able to resolve issues and represents Quality Assurance in cross-departmental/cross-site meetings
• Good judgment and correct decision making based on Pharmaceutical procedures, PQSs, technical experience; and industry guidance/regulatory regulations
• Collaborates and independently engages with a wide range of co-workers, customers, and management within the OpU to gather the input and background knowledge needed to complete assignments
• Identifies issues and reports them to appropriate management attention immediately
• Identifies and takes remedial action or seeks advice when a person or project goal/deliverable is off schedule
• Ability to organize own work to meet project deadlines
• Ability to receive feedback from management and other colleagues takes accountability for actions and personal development
• Effective written and verbal communication and interpersonal skills
• Can generate metrics to support continuous improvement of the site
• Plan and execute projects
• Suggest improvements and participates in continuous improvement activities
• Interface with and represents Quality Assurance in cross-departmental and cross-site meetings, manage working area and projects/changes to accomplish change activities/project deliverables
• Responsible for prioritization and associated timely completion of activities/deliverables
• Support regulatory audits as needed
  
  

About Us

InterSources Inc, a Certified Diverse Supplier, was founded in 2007, offers innovative solutions to help clients with Digital Transformations across various domains and industries. Our history spans over 13 years and today we are an Award-Winning Global Software Consultancy solving complex problems with technology. We recognize that our employees and our clients are our strengths as the diverse talents and opportunities they bring to the table enables us to grow as a global platform and they are causally linked with our success. We provide strategic and technical advice, and we have expertise in areas covering Artificial Intelligence, Cloud Migration, Custom Software Development, Data Analytics Infrastructure & Cloud Solutions, Cyber Security Services etc.

We make reasonable accommodations for clients and employees and we do not discriminate based on any protected attribute including race, religion, colour, national origin, gender sexual orientation, gender identity, age, marital status.

We also are a Google Cloud partner company. We align strategy with execution and provide secure service solutions by developing and using the latest technologies that thrive our resources to deliver industry-leading capabilities to our clients and customers, making it convenient for our clients to do business with InterSources Inc. Our teams also drive growth by refining technology-driven client experiences that put the users first, providing an unparalleled experience. This results in strengthening the core technologies of clients, enabling them to scale with flexibility, create seamless digital experiences and build lifelong relationships.