• Provides direct supervision of Document Control team members
• Promotes a team environment through training, mentoring, and motivating to achieve departmental daily requirements
• Schedules and plans work assignments for the department
• System owner of Document Control System (eDMS)
• Participates in the development and roll-out of document control tools
• Monitors documentation system function, investigates and coordinates with IT on issues
• Writes and maintains document control procedures
• Develops and delivers training regarding document control processes and system changes
• Provides support and guidance for the development and maintenance of site documentation, procedures, work instructions, and templates
• Maintains the document storage room, and manages off-site archiving of documents

Skills: Document Control Supervision, Team Training, Work Scheduling, eDMS Management, Tool Development, IT Coordination, Procedure Writing, Archiving Management

• Follow Policies, SOPs, and work instructions to support the document approval process
• Executes the process for identifying, collecting, distributing, and filing controlled documents
• Issues production batch records, log books, labels, and other quality documents for manufacturing operations
• Ensures the released documentation supporting manufacturing and quality is current, accurate, and processed on time to meet site timelines
• Creates and approves document change requests, manages document workflows, and releases documents to an effective stat
• Supports internal and external audits and regulatory inspections
• Performs routine and ad hoc Document Control metric reporting and analysis
• Provides communication of the status of deliverables to customers, management, and stakeholders
• Be the point of contact between the Operations and Document Control teams.
• Provide direction and guidance to the Document Control team to ensure the completion of assigned tasks

Skills: Document Approval, Document Distribution, Batch Record Issuance, Documentation Accuracy, Change Management, Audit Support, Metric Reporting, Stakeholder Communication

• Perform all Document Control Specialist's responsibilities.
• Develop and update document control procedures and guidelines to ensure correct, consistent, and standardized processes are used throughout project sites.
• Constant interaction with manufacturers to maintain up-to-date software and product changes/updates.
• Clarify document requirements internally with the Project Managers, Engineering, QA, document authors, and process stakeholders.
• Identify training needs and provide training to Document Control Specialists and/or process stakeholders.
• Ensure all necessary controlled document sets are up to date, available, and audited.
• Implement and maintain procedures, specifications, means, and tools
• Ensure an efficient management of all flows of documents either in an electronic form or paper form during all the phases of the project and in all project work locations.
• Provide reports to the Management Team, highlighting progress and any area of concern.
• Observe and impose strict confidentiality in the performance of the documentation management all along the course of the Project.

Skills: Document Control Management, Procedure Development, Software and Product Updates, Cross-Department Collaboration, Training and Development, Document Auditing, Document Flow Management, Progress Reporting

• Manage the work of direct reports.
• Provide guidance, priority, and direction for both day-to-day tasks and long-term projects.
• Performance management of all direct reports, including timely performance reviews, ongoing feedback, and attendance.
• Mentor, develop, and address training opportunities for all direct reports.
• Provide full support for new product introduction (NPI) efforts in the factory.
• Lead the resolution of high-profile configuration projects and problems that have customer-affecting implications.
• Responsible for receipt of customer documentation, securing it in the document control data locations within the site’s customer vault locations.
• Interpret customer and technical specifications, drawings, engineering instructions, and fabrications and communicate requirements to the factory.
• Edit, verify, upload, and release bills of material into the ERP system.
• Perform ERP updates to ensure that operation numbers, AVL, planner numbers, lot control switches, and all other relevant ERP data are current.
• Assign ECO numbers and implement ECO changes in ERP.

Skills: Team Management, Task Prioritization, Performance Management, Mentoring and Development, New Product Introduction Support, Problem Resolution, Document Control, ERP System Management

• Manage parts type (manufacturer and purchase) and parts commodities data.
• Maintain ECO process and attach completed ECOs to the ERP system.
• Maintain approved manufacturer part numbers and alternate accuracy.
• Update and link electronic documentation
• Execute line-for-line reviews of documentation to identify bill of material changes between the ERP and the customer-provided documentation.
• Create, maintain, and distribute product folders
• Support and follow all AS/ISO standards related to NEOTech’s various Quality Management Systems. 
• Support all corporate and site 6S objectives.
• Support and lead continuous improvement (Kaizen) activities.
• Provide input to improve document control processes, templates, and tools.

Skills: Parts Data Management, ECO Management, Part Number Accuracy, Documentation Management, BOM Review, Product Folder Management, Standards Compliance, Continuous Improvement

• Directly related experience with a comprehensive knowledge of industry specifications and standards
• Comprehensive knowledge of composition, grammar, rhetoric, editing, graphic arts, and reproduction processes
• Comprehensive knowledge of technical terminology
• Experience working in a supervisory role
• Communicate effectively, both orally and in writing
• Proficient with MS Office (Outlook, Word, Excel, PowerPoint, Project)
• Sedentary work exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
• Experience working with test repair methodologies
• Familiarity with AUTOCAD, AUTODESK, or Inventor software
• Proficient project management skills
• Lean Six Sigma and ISO 9001 experience or training

Qualifications: BA in Business Administration with 5 years of Experience

• Prior experience with collateral or lien release processes
• Prior supervisory working experience.
• Intermediate MS Excel and Access skills.
• Strong verbal and written communication skills.
• Excellent analytical and problem-solving skills.
• Strong leadership and excellent customer service skills.
• Strong familiarity with mortgage documents.
• Proficiency in report writing
• Good word processing and database skills
• Able to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship

Qualifications: BA in Information Management with 1 year of Experience

• Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Operational experience with electronic quality systems.
• Experience with Document Management Systems (TruVault/Veeva)
• Strong written and verbal communication skills, analytical problem-solving, and conflict-resolution skills.
• Flexible, highly motivated, with strong organizational skills, and the ability to multi-task with attention to detail.
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
• Flexibility in work schedule
• Effective interpersonal skills with the ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.

Qualifications: BA in Operations Management with 4 years of Experience

• Previous experience in an engineering consulting environment
• A broad knowledge of document control systems, as well as industry-specific document control procedures and best practices. 
• Previous experience working with engineering industry-standard technical documents, specifications, data, and design drawings.
• Knowledge and previous experience working with the development of standard document packages and data books related to engineering design, bid, and construction. 
• Must be proficient in the use of document control software.
• Previous experience working with Document Locator, Project Wise, Documentum, Primavera, SharePoint, or other applicable document control software packages
• Previous experience developing and delivering training material
• Excellent written and verbal communication skills
• Strong interpersonal skills, and the ability to clearly and effectively present complex information to all levels of employees, management, and clients.
• The ability to thoughtfully and positively lead, influence, and manage change. 
• Must possess strong project management skills and a strategic perspective. 
• Strong problem-solving and conflict-resolution skills. 
• Must be innovative and creative to provide new document control solutions for project teams or departments. 
• Must be capable of applying extensive and diversified knowledge to broad areas of assignments.

Qualifications: BA in Library Science with 10 years of Experience

• Experience working in document controls
• Membership and/or certification in EMC (Enterprise Content Management) and/or ARMA (American Records Management Association)
• Knowledgeable of document control work processes and utilization of electronic systems for document management
• Understanding of corporate procedures related to document management.
• The ability to perform in a lead capacity
• Excellent written and oral communication skills
• A thorough knowledge of industry practices and company policies and procedures
• Possess a thorough knowledge of database concepts, project-related software, and the ability to train others in its use.
• Outstanding organizational skills
• Excellent analytical and problem-solving skills.
• Excellent attention to detail and organization skills to ensure prompt and accurate evaluation of documentation.
• Proficient with MS Office (Outlook, Word, Excel, PowerPoint, Project)

Qualifications: BA in Records Management with 8 years of Experience