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Job Details

QA/Compliance Tech Writer

Company name
Source One Technical Solutions

Location
Morris Plains, NJ

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QA/Compliance Tech Writer

Source One Technical Solutions

Morris Plains

NJ

Job #668216547

Duties: Author, update, consolidate and review SOPs, work instructions, forms, templates and logbooks in accordance with compliance management oversite and strategy. Present authorship strategy to Quality Compliance & QMS to get pre-approval and endorsement. Other writing tasks as applicable. May be required to support continuous improvement activities and database establishment. Skills: Ability to author technical instructions independently and in accordance with all governing SOPs/GOPs Exceptional ability to proof read and quality check controlled cGMP documents Mastery of Microsoft Word and proficiency in Excel Knowledge of cGMP compliance requirements from a document perspective Interact with compliance and QMS associates with multiple levels of experience in order to determine and rectify any issues/gaps within current procedures. Ability to observe processes and translate into written instruction; identify and close gaps Demonstrate capacity to handle creation/revision of multiple documents and facilitate timely progress through the document lifecycle cycle. Education: (Technical) University/academy degree in biological sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals. 2 - 5 years of pharmaceutical/biotechnology experience in Quality Compliance, Quality Management Systems, and/or Quality Assurance. Required Skills: Interact with compliance and QMS associates with multiple levels of experience in order to determine and rectify any issues/gaps within current procedures Ability to author technical instructions independently and in accordance with all governing SOPs/GOPs Exceptional ability to proof read and quality check controlled cGMP documents Ability to observe processes and translate into written instruction; identify and close gaps Mastery of Microsoft Word and proficiency in Excel Additional Skills: Continuous improvement mindset Ability to communicate clearly (written and verbal) and in an engaging manner with colleagues of various levels of experience and management Comfortable working in a matrix environment and communicating with site and possible other global positions Knowledge of cGMP compliance requirements

Updated 05/17/2018

Company info

Source One Technical Solutions
Website : http://www.source1tek.com

Company Profile
Launched in January 2003, Source One Technical Solutions, LLC is a leading provider of professionals for permanent and consulting opportunities in the areas of Information Technology, Scientific and Engineering. Prior to incorporation, Source One Technical Solutions had been in operation as a Division of Source One Personnel, Inc. since 1998. Headquartered in Bound Brook, NJ, Source One Technical Solutions provides services to clients in the Pharmaceutical, Telecommunications, Financial Services, Retail & Manufacturing, and Health Care industries. Source One Technical Solutions is a MWBE certified company.

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