Documentation Specialist I
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a Documentation Specialist I to be part of our client’ s team in the East Bay Area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
Documentation Specialist I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- This position supports the Development Documentation group, Service Engineers and Application Specialists within the Global Development department. This position will provide documentation and logistics support for a variety of activities, including but not limited to:
- Scan and file hardcopy records of the log sheets for lab cleaning and instrument/Bio-safety cabinets.
- Assist with metadata review and workflow initiation in an electronic documentation management system.
- Manage highly confidential documents in hardcopy format.
- Management of the hardcopy DHF documents in the cabinets and coordinate off-site storage/retrieval.
- Assist with Development employee training management activities – weekly gap report generation, training roster processing, assignment of training requirements to new employees, etc.
- Manage information posted on group collaboration sites.
- Coordinate IQ/OQ documentation activities: request document number, assemble document for execution, route for post-execution approval signatures, scan and post approved documents, ship approved documents to records management.
- Support Instrument Management database for service activities: create general requests and work orders for execution in RAM (regulatory assets management tool) software tool, record service activities in team dashboard, and track activities to completion by following up with the service engineers.
- Support instrument service activities in TrackWise (business-process management tool): transfer information from new RAM work orders into TrackWise tickets.
Summary of Qualifications:
- Minimum of 1-2 years of experience working in a GMP/ISO regulated environment
- Demonstrated proficiency to learn new skills and software
- Meticulous attention to detail to accurately document activities in validated software tools
- Strong organizational, multi-tasking, and time management skills
- Ability to be flexible with changing work priorities and follow procedures/supervisor instructions with a cooperative, can-do attitude
- Strong work ethic and excellent communication skills
- Excellent follow through on assigned action items to ensure prompt support is provided to RMD staff working both internally and at external sites
- High Proficiency w/MS Office required: Word, Excel, PowerPoint
- High aptitude to learn and use other software tools and/or familiarity with:
- MS SharePoint