GMP Document Control SpecialistCategory:Life ScienceEmployment Type:ContractReference:BH-369322GMP Document Control SpecialistGMP Document Control SpecialistBMS ID # 56622-1Bothell, WA- ON SITE12 month W2 contract (with potential to extend or transition to perm)Pay rate: $40-44/hour - Depending on Education and ExperienceSummary:The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.Responsibilities:Issuing production batch records, labels, and other controlled documents to support manufacturing operationsResponsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.Assist with managing the Document Center Archive roomManaging an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective stateMay write and revise document control procedures including participating in the development and roll-out of document control toolsFollow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requestsAssist with cross-training of Document Control personnel and customers to ensure adherence with proceduresExecute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the siteSupport internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspectionsPerform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality dataSkills or Requirements:Strong communication and customer service skills.Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principlesStrong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverablesExperience interacting with FDA or other regulatory agencies strongly preferredStrong knowledge of cGMPs and domestic regulatory requirementsKnowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)Some labeling experience strongly preferredEducation/Experience:Bachelor's degree or equivalentMinimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmentWhat's In It For You?We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.Medical, Dental & Vision Benefits401K Retirement Saving PlanLife & Disability InsuranceDirect Deposit & weekly ePayrollEmployee Discount ProgramsReferral Bonus ProgramsNote: Any pay range