Berkeley, United States
over 1 year ago
This position has responsibility for administration and processing of paper and soft QMS records supporting improvement projects for the Molecular DX Business. This position is located in Berkeley, CA and reports to the Sr. Manager of Quality.
- Review QMS records, scan, and archive as required to meet regulatory/SOP requirements.
- Move files or re-locate files, and package boxes supporting QMS records.
- Interface and manage the record archive process, including P.Os., with approved suppliers for applicable scanning and storage.
- Improve and update applicable record archive tools, such as excel
- Monitor and report action items and task progress and metric updates.
- Review and audit archive data to ensure accuracy and proper disposition.
- Support as required Document processing through interactions with document Process Owners and Quality Representatives to meet all Quality Management System requirements for document processing. Utilizes the document management system ) to add, update, control and make obsolete any Quality Management System documents as requested by document Process Owners.
- Reviews all documents submitted to ensure the use of correct templates and key quality requirements prior to posting the document to the document management system.
- Maintains records of all documents processed according to QMS requirements
- Support as needed database administration, quality assurance, change control administration functions and/or training.
- Quality Assurance review and approval for batch release (Incoming inspection, OEM release, & internal production batch).
Required Knowledge/Skills, Education, and Experience
- Ability to primarily work independently.
- Typically requires 1-2 years successful experience in a document administration role, preferably in a medical device industry or IVD industry.
- Candidate must be detail oriented, to review documents with specific requirements in mind and ensure the posting process is completed.
- Ability to prioritize and organize workload to meet business needs and turnaround time requirements.
- Customer orientation - works in a supporting role and communicates with cross functional teams and partners at all levels in the organization.
- Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents.
- Strong abilities in Microsoft Office applications specifically excel.
- Experience in SharePoint and SAP preferred
- Understanding cGMP and GDP
Preferred Knowledge/Skills, Education, and Experience
- An associate in related field is preferred.
- Knowledge of the Quality System Regulations (in particular, overall Quality management system, Document Management and Record retention requirements)
- Planning and organizing
- Communications skills
- Critical thinking and interpretation
- Stress tolerance and workflow flexibility