Applied Molecular Transport is seeking an experienced Document Control Specialist for our South San Francisco, CA office. The candidate will perform duties to plan, organize, and execute the corporate document control function, such as processing change requests, managing the document control system and archiving records for storage and retrieval.
- Create, edit and make effective controlled documentation related to process changes or document revisions.
- Route Change Requests/document revisions to internal customers and key stakeholders for approval.
- Update, manage, and maintain company procedures and production records in close cooperation with functional area representatives.
- Maintain Master Documents and document trackers for GXP activities.
- Administer SOP training when applicable; train AMT employees and/or contractors on entering and accessing data within the Document Management System.
- Prepare documents for offsite storage, arrange for offsite destruction of eligible documents and conduct audits of offsite archived storage.
- Ability to prioritize multiple competing assignments
- Assist in the establishment of an electronic document storage system.
- Support document control related projects as necessary for other internal groups such as CMC, Facilities and Regulatory Affairs management, etc.
- Assist in the preparation & distribution of document control metrics and reports.
- Provide general support for the overall Quality System.
- 4+ years in document control or records management in a biotech/pharma cGXP environment
- A bachelor’s degree is required
Knowledge, Skills and Abilities:
- Proficient with a computer (MS Office) with internet skills
- Experience from working with many file types
- Be highly organized with attention to detail in a fast-paced environment
- Ability to manage multiple tasks with excellent record-keeping and organizational skills
- Excellent written and verbal communication skills
- Excellent collaborative skills
- Self-Starter with a positive attitude
We invite qualified candidates to submit their CV to: firstname.lastname@example.org (note: ‘Please put job title in subject heading)