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Job: Quality Assurance Specialist II, Medicago USA, Durham, NC

General Information


Job title:
Quality Assurance Specialist II
Job location:
Durham, NC  27709 United States
Requisition code:
Date posted:
08/07/2019
Compensation:
Job category:
Agricultural Biotechnology
Clinical Research
Quality Assurance
Quality Control
Research and Development
Employment type:
Full time

Job Description


Under the supervision of Quality Operations Supervisor, the candidate is responsible for the execution of activities for assigned areas of responsibility within quality assurance programs. Provide support for batch review/disposition, QA on the shop floor support and other Quality Systems such as GMP Materials Management and Quality Events including deviations, CAPA and Change Control.

Tasks/Responsibilities:
• Provide support for the Quality programs/systems governing batch record review and disposition for product release. Ensure required documentation is complete.
• Perform shop floor audits of manufacturing processes, records, and equipment.
• Ensure that associated investigations and change controls are approved by Quality Assurance. Complete required documentation for the review process in accordance with established procedures.
• Perform QA review of CMC documentation, including reviewing and approving manufacturing and QC records
• Author and review SOPs as required.
• Initiate and perform review of deviation and CAPA records. Follow up on all issues to assure each is addressed appropriately. Coordinate needed quality event record corrections with production/QC/facilities group management.
• Author and review SOPs as required.
• Provide support for the GMP materials program by performing disposition activities for incoming GMP production materials.

Job Requirements


Competencies:
• Working knowledge of Deviation, CAPA and Change Control programs with experience in scientific technical writing and reviewing of documentation for these processes.
• Experience with the application of quality assurance systems & regulatory subject matter for batch review and disposition.
• Experience with MS Office & Enterprise applications (example: MasterControl, LIMS, Trackwise, etc) preferred.
• Pharmaceutical manufacturing, packaging, or laboratory experience including at least 2 years in GMP QA/QC/Compliance.
• Must be an organized results oriented self-starter with attention to detail and have the ability to independently and efficiently multitask in a fast paced environment with excellent communication skills (both written and oral).
• While performing the duties of this job, the employee is regularly required to sit and use hands to type or handle various items. The employee is occasionally required to stand, walk, reach or stoop. The employee must occasionally lift and/or move up to 20 pounds.

Education/experience:
• Requires a Bachelor’s degree in technical field and 2 or more years of experience. An associate degree and 3 years of experience will also be considered.
(Job number: 3843676)
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