Summary: The Documentation Specialist will be a member of the PTD South San Francisco Device & Packaging Development 'Business Operations Group'. This group plays a key role in connecting people, processes and systems, to enable compliant and agile team execution. This group is responsible for the following: Records Management, Business Excellence, Digital Systems, Knowledge Management, Project Management, Quality System Implementation, and Staffing to sustain a quality mindset and compliance that enables for filing and inspection-readiness.
Responsibilities: The Documentation Specialist would be responsible for Quality System Implementation, Document Processing & Records Management. This role requires the ability to work in an organized manner, while preparing, formatting, scanning, uploading, and checking GMP Records. This role will also involve ongoing electronic document management including document quality checks as well as data entry and uploading into an electronic system (EDMS).
Other responsibilities for this role include but are not limited to the following:
Document Processing & Records Management Support
Staff Qualification Documentation Support
Project Management of Quality System documentation creation or revision or implementation
Records inventory management
Records Periodic Review management
Records clean up event management
Audit/Inspection backroom support
Skills: Skills Must have the ability to take initiative and work with little supervision. High level of professionalism and the ability to interact with personnel at all levels. High degree of skill and comfort with computer applications and systems. Demonstrate ability to work accurately, follow instructions, and handle multiple priorities. Very strong organizational and communication skills.
Bachelor's Degree preferred
Strong computer skills (MS Word, Excel and PowerPoint, Adobe Acrobat Pro, gSuite) required
Experience with electronic documentation systems (EDMS) required
Experience in pharmaceutical/biotech, medical device and device combination products or other GMP-regulated industry preferred.
Knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to medical device development and device combination products records preferred
Ability to read and understand SOPs and process instructions
Must be detail-oriented with strong organizational skills
Strong interpersonal skills, verbal and written communications in English
This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech