Documentation Specialist I
22 DNA Way, SSF05 South San Francisco, CA 94080
Bayside Solutions is seeking a Documentation Specialist I to be part of our client’ s team in South San Francisco. 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:
- The successful candidate will be responsible for scanning GMP documents using FileNet.
- Other duties include shelving documents and labeling QA file room contents, performing document audits, and generating reports at requested intervals. Effectively follow SOPs, policies, and cGMPs.
- Adhere to and enforce Genentech policies and procedures related to document control.
- Attend cGMP training per department policy.
- Complete SOP and on-the job training per department policy.
- Archival of Document boxes moved from Building 6 (93 total boxes)
- Catch up of all filing necessary in file room (as needed)
- Filing of CR Attachments from QACC. Datasafe and send out attachments for records > 2 years old
- Shred approved records in Building 4 (4331/4333) - One Day of work
- Misc. Boxes from cleanup day that need Datasafing ~6 boxes (Will need to be assessed by someone in QADM prior to assigning work)
- Assistance with QADM “ Clean-Up” activities in the Fileroom (boxking, archiving, etc)
- Final cleanup of Building 4 Fileroom
Summary of Qualifications:
- Candidates must have at least AA/AS Degree and 1-2 years-related work experience.
- Must have 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.
- Demonstrate ability to work accurately, follow instructions, and handle multiple priorities.
- Very strong organizational and communication skills.
- Knowledge of cGMP regulations and concepts preferred, particularly in good documentation practices.
- Experience in pharmaceutical/biotech or other GMP-regulated industry preferred.