GMP-GMP Source Production Coordinator in Fargo, North Dakota For Sale
Position Summary:
This GMP-GMP Source Production Coordinator will support the manufacutring process by managing staffing and production to ensure the timely and accurate completion of projects. This position is expected to generate data and metrics, complete reports, monitor production, and execute CAPAs. The GMP-GMP Source Production Coordinator is expected to become familiar with all of Aldevron's products and to be able to perform most tasks associated with the purification of plasmid DNA.
Essential Duties and Responsibilities:
Assist with maintaining a documented production schedule for staff, manage staffing resources and vacation requests
Plan and schedule facility and equipment maintenance tasks with Metrology as appropriate with scheduled resources
Coordinate with Research Grade, Metrology, Quality Control, Quality Assurance and Project Management as needed on the scheduled production. Update Project Management on production status as needed.
Assist with reviewing production kick off memos
Assist with updating, and writing SOPs and forms as needed
Plan and prepare GMP-Source shipping schedule. Work with Project Management and shipping personnel on planning and scheduling
Coordinating schedule and resources for execution of CAPAs and ensuring timelines are adhered to. Working with the GMP/GMP-Source manager as needed on any issues
Responsible for following Aldevron SOP's and adhering to regulatory expectations
Execution of Corrective Actions and deviations
Assist with tracking the status and approval of Raw Material Authorization paperwork
Review dashboard, and ensure staff are updating appropriately
Work with Document Coordinator(s) as needed to review archival records that have reached the retention time to determine if they should be destroyed or retained for another life cycle
Schedule classroom training events for new staff (Good Documentation Practices, AssuRx, etc.)
Assist with classroom training of Aseptic Technique Modules
Assist with Quality Metrics. Ensure staff are updating Metrics sheets appropriately
Coordinating the documentation of non-conforming materials, ensuring Material Review Board meetings are scheduled. Track the Material Review Board process
Assist with lot tracking and date of manufacture tracking
Schedule and prepare agendas for internal meetings upon request
Ensure all quality documents within the Document Control system are maintained effectively, which includes to ensure periodic review schedule of documents is met. As well as to ensure procedures are maintained in a manner clearly defining the process steps and in enough detail to provide the necessary guidance to any individual following the procedure
Ensuring document periodic review tasks are completed on time
Qualifications:
Experience:
5 Years or more related experience preferred
Education:
BS/M Degree in Biology, Chemistry, or Molecular Biology
Skills and Knowledge:
Effectively communicate both verbally and in writing
Apply basic math (arithmetic, ratios, proportions and conversions)
Work as a team member
Ability to follow written procedures, and written and verbal directions
Keep records and maintain files
Good knowledge of computers and programs, like Microsoft Office, and Smartsheet
Good organizational skills
Ability to self-report mistakes or concerns to their manager
Knowledge of preparing and producing reports, documentation, and scheduling
Adhere to safety, health, and sanitation procedures
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.
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