Document Control Senior Specialist

and those authorized to work in the U.S. can be considered as W2 candidates. Location: Berkeley, CA 94710Duration: 12 monthsPay Rate: $25-55/hourDocument Control Senior SpecialistQA Documentation. Support documentation needs for the entire site including document processing, issuance of production records and archiving of physical records.POSITION SUMMARYTo provide documentation support for vaccine manufacturing operations. To process controlled documents from generation through approval and archiving; issue batch production records, logbooks, or serialized paper to the site to support vaccine production.POSITION DUTIES & RESPONSIBILITIESPosition is a Document Control Senior Specialist 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 project priorities and maintain GMP documents in a compliant state.- Coordinate and track project documents to ensure project timelines are met.- Works within own department and interfaces with internal groups on specific tasks/assignments.- May monitor production schedules and provide Batch Production Records, or 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):- Requires a BS/BA with curriculum focus in writing, editing, publishing or equivalent experience in a QA documentation environment.Skill & Competency Requirements: - 3-5 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.- Ability to influence others without direct authority.- Exceptional ability to communicate and collaborate with cross-functional partners to meet compliance requirements and project goals.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).- Prefer basic project management and leadership skills.- Ability to manage multiple priorities within tight timelines.