Document Control SpecialistPosted: November 6, 2009
ATS is an information technologies consulting company providing services to Fortune 500 companies nationwide. ATS specializes in providing full-service staffing solutions by providing technical and business personnel through staff supplementation and project engagements. The company has extensive contacts within its Fortune 500 client base and is able to access a large pool of talented and responsive professionals with proven records of accomplishment in both the technical and business fields.
We are currently seeking a Document Control Specialist who Manages release and control of updates to instructions, drawings and other documents. Controls distribution of new releases and recall-destruction of obsolete documents. Support the records management project objectives. Prepare periodic status reports. Accurately sort, file, mail and copy critical-vital records. Accurately input data in a database spreadsheet and provide reports as requested. Answers telephone, conveys message, communicate to corporate via phone and e-mail. Copies documents, using office-duplicating equipment. 4 years experience
Candidate will facilitate the overall document management process for both clinical and non-clinical processes, including: Standardized forms and templates for the development of controlled documents; Technical Writing Formatting, Grammar and Quality Check. Ownership and maintenance; electronic approval of all controlled documents. Storage of all controlled documents; Creation and maintenance of controlled document files and archival of as appropriate. Ownership for the development and maintenance of document development tools, including planning calendar, reports, Table of Contents, etc.
Evaluate new regulatory, compliance and/or legal guidance and develop impact analysis and prepare implementation plans on process, SOP and training as needed. Develop and revise standard operating procedures (SOPs), work instructions and associated forms..Specific responsibilities include: drafts SOPs using SOP WORD template; ensures that SOPs meet all applicable regulatory, financial, and legal requirements and are consistent with the practices other departments and policies and procedures; coordinates review of SOPs and collect inputs from other SME reviewers; revises documents accordingly and ensures appropriate approval
BA/BS in biological sciences, nursing or related discipline or equivalent experience is required. A minimum of 5 years experience within a pharmaceutical, biotech, or CRO clinical research in an operations group.
In-depth knowledge of GCP, ICH regulations/requirements, and understanding of clinical trials including global trials required. Prior experience in process development is required
Must have excellent English writing ability and fluency in spoken English. Proficiency is Microsoft office applications (including Word, PowerPoint, and Excel).
ATS offers health coverage, 401K participation, Long Term Disability and Life Insurance. Please refer to job code 09-01062 when responding to this ad.
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