QA Documentation Support

and those authorized to work in the U.S. can be considered as W2 candidates. Key information for candidates -Location: Berkeley CA 94710Title: QA Documentation SupportDEPARTMENT/TEAM DESCRIPTIONQA Documentation. Supports documentation needs for the entire site including document processing, issuance of production records and archiving of physical records.POSITION SUMMARYTo provide documentation support for Berkeley Product Supply manufacturing operations. To process controlled documents from generation through approval and archiving.POSITION DUTIES & RESPONSIBILITIESPosition is a Document Coordinator position in QA Documentation.•Direct the flow of controlled documents (SOPs, CDRs, MPRs, sampling tables) through creation, revision, and issuance from initial request through final approval (electronic workflows) and distribution within customer service document turnaround times required to support production timelines.•Review proposed changes to documents to ensure complete traceability for document change control history.•Perform technical word processing and editing of documents that include moderate-to-high degree of formatting. Provide assistance to eDMS users as required.•Work with internal departments to ensure document workflow requests are completed in a timely manner to support site priorities and maintain GMP documents in a compliant state.•May coordinate document effective dates, to meet product release goals.•May Issue and Archive Equipment and Facility Logbooks or issue Serialized Data Record paper to QC Laboratories and production.•Maintain document databases to support metrics to monitor and report on document preparation and approval cycle times, and other key site performance indicators (KPI).REQUIREMENTS/PREFERENCESEducation Requirement(s):•Prefer a BS/BA with curriculum focus in writing, editing, publishing or equivalent experience in a QA documentation environment.Skill & Competency Requirements: •2-4 years of experience performing relevant activities including working in a GxP compliant environment.•Basic grammar skills are required.•Strong word processing and proofreading skills a must.•Extensive knowledge/experience using MS Word.•Must work with accuracy and attention to detail.•Must work well with others and be a team player. Interpersonal skills highly valued.•High communication skills a must.Preferences: •Prefer hands-on document preparation and editing experience or extensive data entry and verification experience in a GxP environment.•Knowledge/experience using an electronic document management system (eDMS).•Ability to manage multiple priorities within tight timelines.•Why is this position open? Growth on the team, turn over, skills gap? Back fill for transfer of resource to a project•Location of this role site or remote? Berkeley, remote at first then hybrid•Tell me about the team dynamic/culture. Very diverse and laid back•What are the 'must haves' to be successful in this role? Detail oriented, team player•What will make this opportunity stand out for potential candidates? Working with varied customer base.•What kind of soft skills are you looking for? Great communicator and highly organized•Is there a possibility for an extension of this assignment? Yes•What is the interview process, will you schedule a phone screen, video conference or in person interviews? Video conference