This person will support the Sanford, NC Quality Assurance department by performing Quality Operations Systems activities related to LIMS associated with clinical and commercial products, raw materials, validation, stability, and environmental monitoring.
They will demonstrate the following:
* Knowledgeable of the principles and concepts of current Good Manufacturing Practices (cGMPs) and company Quality Standards to be a key contributor
* Capability of understanding requirements of LIMS builds
* Capability of designing queries to retrieve LIMS master data
* Identifies issues and reports them to appropriate management attention immediately Able to resolve issues and represents QO in cross-departmental meetings
* Ability to identify issues, present complex problems with possible solutions, and actively takes leadership role to resolve those issues
* Good judgment and decision making based on procedures, PQSs, technical experience; and industry guidance/regulatory regulations
* Collaborates and engages with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments
* Identifies and takes action/seeks advice when a personal 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
* Responsible for prioritization and associated timely completion of activities/deliverables
* Support regulatory audits as needed
Day to day:
* Responsible for building and testing new LIMS builds and LIMS Master Data changes.
* Responsible for creating queries to retrieve LIMS data to support investigations and other business processes
* Review and approval of site documentation including but not limited to, change controls and SOPs in a timely manner
* Manage priorities to accomplish change activities/project deliverables; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
* Reports issues and elevates them to appropriate management attention immediately
* Can independently manage workload based on priorities
* Identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.