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Document Control Administrator
The Document Control Administrator is responsible for providing guidance and support to the organization by providing documentation services for all quality records in such a manner to support the accrediting agencies for FDA regulated products. They will be responsible for the Documentation system, Engineering Change Control system, Periodic Review system, the training program and the document archive system.
- Is responsible for coordinating the paper-based documentation program from document number assignments through processing documents and engineering change orders.
- Is responsible for filing and maintaining all quality records.
- Assigns new document numbers and provides document templates.
- Moves documents to the appropriate folders for revisions, additions, removals or obsoleting of documents.
- Works with internal customers to resolve document format issues such as fonts, tables, pictures, step numbers, template formats and even re-writing or writing the document for the internal customer.
- Assigns document numbers (QUA, GOP, etc.…) to new quality records.
- Is responsible for the Engineering Change Control (EC) process from initial number assignment, review of package for completeness, generating signature approval pages, labeling attachments, determining appropriate signatures, generating signature pages, prepping & moving document, etc.
- Is responsible for the Periodic Review process and ensuring documents are assessed in the allotted time frames.
- Is responsible the organization of all Quality Records, physical and electronic versions.
- Updates Quality logs when quality records close.
- Is responsible for the training program tracking and trending and metrics.
- Maintains accurate and detailed records in accordance with GLP, GCP, regulations.
- Must understand and demonstrate compliance with all applicable regulatory requirements.
DESIRED KNOWLEDGE, SKILLS AND EXPERIENCE
- An associate’s degree in a related life science field and a minimum of 3 years of experience OR
an equivalent combination of education and experience is required.
- Experience with FDA and ISO compliance requirements for documentation of quality required.
In addition, should possess:
- Be organized, self-motivated and have strong oral and written communication skills;
- Be highly self-motivated;
- Possess strong organizational skills, time management and planning skills;
- Possess exceptional interpersonal and communication skills, work well with others, be a team player;
- Possess strong Word, Excel, PowerPoint and form creation skills;
- Access and Pivot table skills are a plus.