Exela Pharma Sciences, LLC Hiring for Quality Assurance System Specialist job in Lenoir Full Time

The Specialist, QA – Systems will be responsible for managing deviations, CAPAs, and/or managing change controls in the Veeva Digital system. The Quality Systems specialist will support GMP activities to ensure compliance with regulatory and company requirements.

Job Responsibilities:

• Assist with building and approving change controls in Veeva.
• Assist with building and approving Deviations in Veeva.
• Assist with building and approving CAPAs in Veeva.
• Write/update SOPs and other documentation pertaining to Quality Systems
• Potential participation in health authority, 3rd party, and internal inspections
• Perform other duties as assigned

Required Skills:

• Ability to meet varying deadlines
• Ability to coordinate projects involving input from multiple participants
• Ability to work independently and as part of a team
• Ability to read and write English, follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors
• Ability to interact with others in a diplomatic and assertive manner while maintaining a teamwork attitude
• Ability to sit and/or stand for extended periods of time, must be able to climb stairs
• Ability to lift and carry 25 lbs
• Ability to walk while carrying items
• Ability to see very small print and tiny graduations

Education and Experience Requirements:

• Bachelor’s degree and 2 years working experience in the pharmaceutical manufacturing industry or related healthcare field required
• Proficiency in Microsoft Office applications (e.g., Excel, Word, etc.) and Adobe Acrobat
• Previous experience with pharmaceutical deviations/change control/CAPAs; or an equivalent combination of education and experience sufficient to indicate the ability to perform the duties of the position

EOE Disability/ Veterans