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QA Document Control Specialist

Company: Automated Systems, Inc.
Location: Saint Petersburg
Posted on: November 22, 2021

Job Description:

QA Document Control Specialist Job Role Summary: Shift: 11am-8pm, M-F ,Onsite Maintenance of the Document Change Request database. Maintenance of Quality Assurance files for Document Change Requests. Conducting lifecycle management of quality documents within Documentum. Authoring and modifying SOPs with input from the change initiators. Conducting controlled copy printing of master batch records for the production floor. Issuance of controlled copy reprints for master batch records. Printing, binding, and distribution of controlled logbooks for all departments. Conducts off-site storage and retrieval of controlled documents and records in accordance with proper document retention and Corporate policy. Assists in the preparation for and facilitation of regulatory and customer audits. Team. Serves on site project teams. Interfaces with Engineering, Quality Control, Technical Services, Validation and Manufacturing management in support of providing documentation support for new product introductions and for changes to existing products. Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress Customer Focus. Support Technical Services/ Engineering/Quality Control/Validation schedules in accordance with customer and internal project commitments to minimize disruption of the project and provide documentation in support of business needs. Interact with counterparts and customer personnel to ensure quality expectations are met. Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Companys Quality Policies. Participates in the creation and review of current and proposed procedures. Ensures compliance with cGMPs and departmental procedures. Proposes and assist in the implementation of quality improvements to document control systems. Participate in additional quality initiatives as required (e.g. Internal assessments, CEC, etc.) Requirements Education or Equivalent: Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background in chemistry or microbiology is preferred. Requires a minimum of 3 to 5 years experience with documentation systems. Requires a minimum of 1-2 years' experience in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems. SKILLS: - Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. - Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, and JDE is a plus. - Proficient technical writing skills are required. - Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications. - Capable of quickly learning new quality systems and associated software applications for proficient execution of tasks. - Must be capable of managing multiple projects with time related constraints in a fast paced contract manufacturing environment. - Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employee. Job Requirements:Organizing and maintaining document control systemEnforce project quality control processesManage the document and change control processAssisting with the process of document controlExecuting all functions related to document controlMaintain process control and data gathering systemsMaintain the plant's process control systemEnforce document control requirements and rules for standardsProvide training to customers on electronic control systems operationsEnsure the proper change control of all documentsProviding back-up document control support as needed on other projectsProvide support related to change control investigationsProvide change control technical assessment, support, and approval for controlled document changes, including new change control system implementationOversee vendors for work performed on control systemsMaintain all the Facilities electronic control systemsWork on new and existing control systemsMaintain spec control logs, drawing control and requestsProviding or coordinating technical assurance of control systemsCommunicate and coordinate document control activities with all departmentsAssist in the task orders initiation and procedure

Keywords: Automated Systems, Inc., St. Petersburg , QA Document Control Specialist, Other , Saint Petersburg, Florida

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