Job: Quality Assurance Specialist III, Medicago USA, Durham, NC
Quality Assurance Specialist III
Durham, NC 27709 United States
Research and Development
Manufacturing and Production
Under the supervision of the Quality Compliance Supervisor, the candidate is responsible for the system administration of the electronic Quality Management System (eQMS) as the lead for the Document Modules in Mastercontrol with backup responsibilities for the Training Module.
• Serve as Site Administer of the eQMS (MasterControl).
• Act as lead for system upgrades for the North Carolina site in coordination with Corporate QA.
• Liaison with Corporate QA to harmonize processes and procedures.
• Manage and maintain public organizers in MasterControl.
• Responsible for the coordination of document control workflows (SOPs, forms, manuals, policies), including development and maintenance of associated policies, databases, master lists, and document management programs.
• Perform data entry, record issuance, retrieval, audit/reconciliation, and archive tasks supporting QA programs.
• Prepare and provide timely and accurate reports and assessments of assigned project(s)' status to QA Management.
• Provide Records Management support as needed; to include: importing records into official electronic repositories (convert hard-copy records to an electronic format if necessary).
• Create and/or maintain indexes in order to track records and provide work metrics as required.
• Ability to be flexible as well as handle and prioritize many projects at a time.
• Hands-on Experience being a System Administrator for eQMS, preferably MasterControl. Other similar eQMS will be considered.
• Knowledge and experience with implementation and coordination of cGMP compliant Document, Records, Training, and Information Management systems, as well as related software systems.
• High level of proficiency with MS Office and Adobe Acrobat applications required.
• Must be able to demonstrate abilities to contribute and coordinate the development, implementation, and maintenance of existing programs and/or new practices/processes by identifying and applying improved approaches to typical problems.
• Proven technical expertise with the application of problem solving knowledge and experience with creativity and adaptation of standard methods/practices such as the analysis of multiple variables and complex technical elements.
• Experience with cGMP manufacturing operations and process development required.
• Must be well organized and have the ability to multitask in a fast paced environment.
• Attention to detail, good documentation practices, and proofreading skills with logical step-wise problem solving ability.
• 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 25 pounds.
• Requires a Bachelor’s degree and 4 or more years of life science industry experience working directly with MasterControl or similar eQMS; An Associate’s degree and 5 years of life science industry experience will also be considered or equivalent work experience.
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