• Provide change control and documentation storage services
• Organize and conduct Engineering Change Orders (ECO) meetings
• Track ECOs to ensure agreed changes to the document are made and accurate revisions are on hand
• Capture and monitor Change Implementation Plan (CIP) actions to ensure ECO is fully implemented
• Responsibility for problem-solving, maintaining, and improving processes
• Provide training and assistance to documentation enquires
• Issue part numbers, maintain reference data for documentation in the database
• Verify changes to the Bill of Material (BOM) and update in the ERP system
• Provide and track dataset/documentation to suppliers and customer
• Issue Temporary Deviation Notices (TDN) and monitor to completion

Skills: Change Control, ECO Coordination, Revision Tracking, CIP Monitoring, Process Improvement, Documentation Support, Part Numbering, BOM Management

• Manage and maintain controlled documents (paper and electronic) in support of the quality management system
• Review incoming documents for completeness and determine the proper filing category for accurate archival, retrieval, and record-keeping
• Oversee the scanning and upload of documents to the document management system
• Take charge of all document identification, classification, and filing
• Assist internal audits and regulatory inspections through the retrieval and coordination of documents
• Assist with training employees in controlled document processes
• Ensure correct handling of documents and maintain training matrices for all Quality documentation and employee training files
• Oversee the document through its entire life cycle (inception to archival)
• Check and edit incoming documents and prepare for distribution
• Create and maintain document filing and organizing systems that are both effective and efficient
• Ensure proper organization and security of documents (paper and electronic)
• Make available, notify, and distribute documents to relevant recipients
• Support other QAQC functions such as inspection and testing, nonconforming material processing, etc.

Skills: Document Control, Filing & Archiving, Scanning & Uploading, Classification, Audit Support, Training, Lifecycle Management, Document Distribution

• Responsible for creating, maintaining, reviewing, and implementing all controlled documentation within the company.
• Performs the Document Control function and assists with implementation of Document Control Software such as Master Control.
• Coordinates and chairs Change Control Board meetings.
• Assist with the documentation and planning of Quality Committee Reviews.
• Assist in supporting external audits, coordinating activities in the backroom, and ensuring timely response to documentation requests for auditors.
• Supports change management of labeling and ensures accurate completion of Labeling Verification form.
• Administers training regarding documentation policies and procedures.
• Maintains quality records per applicable SOPs.
• Investigates and responds to corrective actions related to Document Control, Training, and External Standards.
• Responsible for coordinating document change orders (DCO), and facilitating review, approval, and retention of Risk Management documents.

Skills: Document Creation & Maintenance, Document Control Software, Change Control Coordination, Quality Review Planning, External Audit Support, Labeling Verification, Documentation Training, Corrective Action Management

• Daily monitoring of project correspondence tool.
• Storing and distribution of supplier documentation.
• Storing and distribution of incoming RoRs/Customer review feedback.
• Preparing and sending transmittals of project documentation and RoRs.
• Upload of documentation to Customer’s system when contractually required.
• Monitoring and quality assurance of metadata.
• Frequent follow-up of internal reviews of supplier documentation.
• Handling the process of translation of project documentation.
• Linking documents to structure for installation and final plant.
• Interface with the printing company for printing installation documentation.
• Handling the process of updating installation documentation.
• Provide input to Project Documentation Manager when needed e g project status, issues, etc.

Skills: Project Monitoring, Doc Distribution, RoR Management, Transmittal Prep, Doc Upload, Metadata QA, Review Follow-up, Translation Management

• Performs data entry 45% of the time to process documents and Engineering Change Notices.
• Adheres to configuration control requirements, processes, and procedures as well as performs ongoing configuration audits.
• Works with other departments on continuous improvement of the Enterprise Change Order (ECN) process.
• Plays a key role in the implementation and maintenance of Product Data Management (PDM).
• Maintains all departmental quality documentation and various configuration management software applications (e.g. Syteline).
• Enforces Copy Exact policy and any other applicable policies.
• Uses Configuration Management guidelines to coordinate the flow and completion of documentation associated with ECNs and Deviations Reviews.
• Coordinates with other departments in facilitating ECNs and tracks to ensure that they are complete on time for all product changes.
• Maintains ECN and product data archives.
• Releases original issues of product data.
• Releases parts and documents to production (in ERP and vault, performs standard drawing verification).
• Conducts verification on implemented ECN to ensure the redline of intended change matches what was specified on the ECN request and/or obtains verification from engineers.
• Releases updated drawings and changes to the vault and closes ECN.
• Reviews, tracks, and coordinates the processing of deviations.

Skills: Data Entry, Configuration Control, Process Improvement, Product Data Management, Quality Documentation, Policy Enforcement, ECN Coordination, Product Data Archiving

• Administrate document control and change management process and system.
• Create, maintain, and optimize existing product configuration rules with SAP Product Configurator.
• Engineer Records Oversight (for documents released to manufacturing).
• Enforce adherence to controlled document changes.
• Take responsibility for issuing part numbers.
• SAP functional module expert for Variant Configuration and Engineering as part of an integrated business solution.
• Establish workflows to maximize efficiency and reduce wasted effort.
• Establish good working relationships and technical integrations with manufacturing, purchasing, and supply chain.
• Resolve system issues, define mass data changes, test system functions, and train super users.
• Work with the engineering team throughout the project life-cycle to ensure requirements are being satisfied by the planned SAP-configured designs.
• Set up Options, Characteristics, BOMs, and rules in SAP VC based on the input from engineering.
• Perform product SAP VC acceptance testing and validation.
• Collect, document, and communicate best practices affecting product configuration utilizing ERP.
• Develop queries in SAP to extract and analyze data to provide a better understanding of production issues to drive more efficient operations.
• Work closely with product management, engineering, production planning, and support teams to ensure that new products are properly set up in SAP at product launch.

Skills: Document Control, Change Management, SAP Product Configurator, Engineering Records Oversight, Part Numbering, Variant Configuration, Workflow Optimization, Cross-Department Collaboration

• Assist the Sr. Quality System and Compliance Engineer with authoring and revision of quality system procedures, specifications, SOPs, work instructions, manufacturing batch records, and forms.
• Perform document processing and records handling, accurate data entry into databases.
• Review documents for accuracy, completeness, and compliance.
• Identify changes needed for existing documentation processes to support continuous improvement.
• Serve as a change agent, training colleagues and providing understanding of document control and records management practices ensuring compliance of these practices across the organization.
• Support Quality audits and technical visits.
• Review and control of documentation supplied by customers.
• Manage the Calibration Compliance System, and make sure equipment is calibrated.
• Maintain the documentation control system for the company.
• Manage the system that encompasses equipment drawings, machine and R&D facility layouts, product specifications, procedures, and technical literature.
• Review existing documentation with various departments to ensure documentation is up to date.
• Work directly with R&D, Manufacturing, Quality, and other departments to develop forms and processes.
• Communicate document revision status, appropriate routings, and importance levels to the appropriate contacts and arrange for the timely release of those documents.
• Manage the documentation database and keep it current to ensure high accuracy.

Skills: Document Authoring, Data Entry, Document Review, Continuous Improvement, Change Management, Calibration Compliance, Documentation Control, Cross-Department Collaboration

• Responsible for or supports the following activities associated with product development, specifications for manufacturing, and quality management system documentation
• Route documents electronically for review and approval and track completion.
• Serve as liaison between document originators and departmental reviewers and approvers.
• Assist R&D Project Leaders with design control documentation routing
• Design History File documents and Technical Specifications such as BOM, Drawing, Labels, IFU, Raw Materials
• Support new product launches in loading and routing new specifications (including external contract manufacturer documentation).
• Support sustaining engineering efforts on existing products, managing document activities related to Engineering Change Orders (ECO).
• Support or co-manage the document and document control process, including working directly with authors, reviewers, and approvers to facilitate document and document order workflow
• Ensure proper document organization, and ensure required custom fields and other applicable data inputs for compliance are provided.
• Manage document control workflows that include receiving submissions in Master Control, attending change control board meetings, and routing required documentation.
• Create and revise material specifications in ERP, PLM, and/or QMS systems along with updating BOMs
• Ensure the data entered into the ERP System is consistent and adheres to in-house processes.

Skills: Document Routing, Design Control, Technical Specifications, Product Launch Support, Engineering Change Orders (ECO), Document Control Management, Compliance Data Entry, ERP/PLM/QMS Systems

• Ensure compliance with all regulatory requirements for creation, revision, processing, filing, on-site and off-site storage, retrieval, and disposition of controlled documents at the facility.
• Support the review, routing, distribution, and archival of GMP documentation.
• Assist with process requests for document changes, coordinate SOP review meetings, and periodic review of documents.
• Update and maintain document tracking databases and archival systems.
• Participate in writing and reviewing Document Control associated SOPs proactively, work with others to build consensus and solve problems, and assist authors with the creation and revision of SOPs.
• Maintain SOPs, Batch Records, and other documentation related to QA, and manage the control of other documentation and records.
• Support the Lot Release QA function by preparing Lot Release documentation and trending lot-specific quality data.
• Implement appropriate corrective actions to reduce delays in the product release process and ensure customer satisfaction.
• Provide support to the functional groups within the company on good documentation practices, document control requirements, and documentation processing.
• Assist with supporting audit and regulatory inspection activities.
• Identify and implement improvements when gaps are identified through audits and departmental reviews.
• Lead and participate in efforts to implement an Electronic Documentation Management System.
• Control the retrieval of documents, and receive and process requests for information from employees.
• Maintain requests for information in tracking logs.

Skills: Compliance, GMP Management, SOP Coordination, Document Tracking, SOP Creation, Batch Records, Corrective Actions, Document Management System

• Responsible for managing all aspects of the document control process from document creation, through collaboration, approval, release, and ultimately to retirement
• Serves as the Master Control system Administrator SME and provides training/guidance to system end-users, and in instructor-led settings
• Systematizes and streamlines document workflows
• Maintains training materials for the various levels of system users
• Prioritizes Change Control activities and drives Change Notices to completion using metrics and periodic reporting
• Compiles process metrics, identifies trends and escalates accordingly
• Manages the release and control of updates to policies, procedures, instructions, etc.
• Manages Quality records and programs including Vendor Management and Approved Supplier List, Organization Chart, GMP Signature Logbook, Environmental Monitoring, electronic and off-site document archiving
• Communicates effectively with cross-functional and external stakeholders on matters related to documentation systems
• Manages the inter-company Change Control/ECN process
• Assists in third-party ISO and GMP audits
• Implements best practice solutions to improve and maintain the QMS documents and CN process

Skills: Document Control, Master Control System, Workflow Streamlining, Training Development, Change Control Management, Process Metrics, Quality Records Management, ISO/GMP Audits

• Equivalent experience in a records/documentation center
• Relevant experience in the pharmaceutical, biopharmaceutical, or life sciences industry
• Experience with documentation in a regulated environment and electronic tracking of documents using Regulus or Zasio
• Ability to work four 10-hour shifts, 3 weekdays plus one weekend shift
• Strong knowledge of computer applications in the Microsoft Office suite
• Experience working in an environment that adheres to strict standard operating procedures
• Extraordinary attention to detail and follow-through along with the ability to multitask regularly
• Self-directed and motivated with the ability to work independently as well as collaboratively in a team environment
• Availability for some overtime to support internal or external audits
• Ability to climb stairs, bend and reach for filing, lift to 30 lbs. 
• As part of periodically moving/organizing file boxes

Qualifications: BA in Information Management with 3 years of Experience

• Experience with document processing and data management
• Previous experience in a construction environment, with an understanding of the construction process and coordination of various entities in the industry.
• Previous experience managing a Document Control effort for a large-scale construction project
• Must have a self-starter attitude with a proactive, results-oriented focus, and willingness and capability to assume additional responsibilities.
• The ability to troubleshoot and be solutions-driven.
• Proven accuracy, reliability, and completeness in job accomplishment. 
• Demonstrated success on the job, as evidenced by satisfactory performance, acceptance of responsibility, and growth in previous positions.
• Prior SCA working experience
• Effective oral and written communication skills, with detail-oriented and highly organized
• Able to interface with a variety of people with different technical levels and educational backgrounds
• Must be able to produce accurate and timely results while maintaining a positive customer service attitude.

Qualifications: BA in Project Management with 4 years of Experience

• Experience with the management of document/records management program
• Experience within or exposure to the Oil and Gas Industry
• Knowledge of information management systems, such as Livelink, SharePoint, Aconex
• Understanding of revision control and review/approval process
• Ability to work independently at a task as well as collaboratively within a team and with others outside the formal organization.
• Previous knowledge and working experience of computer software, such as Microsoft Office (ie, Word, Excel, Outlook, Powerpoint, etc.) and Adobe Programs, Bluebeam
• Exceptional analytical and problem-solving abilities with a high level of attention to detail.
• Knowledge and understanding of document workflow and life cycles
• Technical knowledge in understanding and applying records/ data and document management oracle, concepts, tools, and technology
• Understanding and appreciation for the diverse needs of different users of electronic document management systems
• Experience in an engineering environment, taxonomy, metadata, and document management practices
• Hold ECMS, ECMM, RM, or AIIM certification

Qualifications: BA in Library Science with 6 years of Experience

• Experience related to the filing, control, retrieval, and/or review of documents and records
• Experience working with PLM/document control systems
• A good working knowledge of Arena or Macola
• High attention to detail and concern for standards
• Critical thinking with the ability to prioritize multiple projects simultaneously in a dynamic environment
• Proficient with Microsoft Word, Excel, and Outlook
• Strong follow-up and organizational skills
• Excellent verbal and written communication skills
• Ability to make decisions and work with minimal to moderate supervision
• Strong sense of ownership and membership of the team

Qualifications: BA in Administrative Support with 1 year of Experience

• Experience working with document control systems.
• Knowledge of Configuration Management standards (EIA-649B, etc.)
• Ability to balance CR/CN status accounting between programs, contracts, and customers
• Skill and knowledge required to train and mentor others
• Ability to document and adhere to standard processes and procedures
• Appropriate skills with several software tools (Word, Excel, IFS, Windchill PDM)
• Proficiency with Document Control and Configuration Management practices, including Change Notices, Configuration Control Board (CCB), and BOMs
• Extensive knowledge of Windchill PDM ERP software suite
• Familiarity with ISO 13485:2016 standard
• Self-starter and problem solver with accurate and timely communication skills
• Excellent organizational skills and attention to detail

Qualifications: BA in Communication Studies with 3 years of Experience

• Prior experience in a biotech or pharmaceutical company
• Experience with Document Control Systems in a Biotech, or Pharmaceutical company.
• Knowledge and overall understanding of biopharmaceutical manufacturing and manufacturing support processes.
• A good working knowledge of FDA requirements for GMP compliance.
• Advanced ability with various computer systems and experience using Microsoft Word and Electronic Document Management System (EDMS).
• Must be able to complete assigned tasks independently with minimal instruction and have the initiative to obtain guidance on new assignments when needed.
• Commitment to quality and pride in work
• Excellent written and verbal communication skills
• Able to maintain knowledge of cGMPs, which may involve attending training sessions.
• Must be able to maintain a high degree of confidentiality and professionalism
• Have excellent proofreading and grammatical skills, with good attention to detail.
• Must be able to work well with personnel at all levels of skill and authority throughout the company

Qualifications: BA in Management Information Systems with 7 years of Experience

• Experience as a Quality specialist or equivalent (electronics industry)
• Experience using an ERP system, Microsoft Dynamics Axapta
• Experience with MIL-PRF-19500, MIL-PRF-38534, MIL-STD-750, AS9100
• Proficiency in Microsoft Word, Excel, PowerPoint and Outlook
• Good computer/keyboard skills
• Self-starter with excellent interpersonal and communication skills
• Excellent attention to detail
• Ability to read, analyze, and interpret common scientific drawings
• The ability to work with minimal supervision
• Strong oral and written communication skills and strong interpersonal skills with the ability to build positive relationships with individuals of all levels
• Ability to extract relevant information from slash sheets and datasheets for paperwork creation
• Aptitude for understanding technical details pertinent to paperwork creation

Qualifications: BA in Operations Management with 6 years of Experience

• Previous support working experience
• Experience in maintaining a document control system within a regulated environment
• Experience working with contract management software
• Strong knowledge of GMP, SOPs, and quality system processes.
• Strong interpersonal and communication skills, both written and verbal, and a professional demeanor
• Must be detail-oriented, have excellent organizational skills, and can multi‐task.
• Proficiency with Microsoft Office Package, with a strong understanding of Word, Excel, and Outlook.
• The ability to complete work assignments independently
• Exceptional customer service skills and ability to comply with client procedures.
• Ability to read, write, and speak English proficiently

Qualifications: BA in Records Management with 1 year of Experience

• Familiarity with archiving/indexing servers, folders, and databases
• Able to properly set up the database/folders for ease of access, with limiting control (read-only and read/write access privileges)
• Experience in maintenance and control of all documents - detail drawings, BOMS, parts lists, wire lists, assembly drawings, procedures, test plans and reports, and manuals
• Experience with SolidWorks Enterprise PDM or similar CAD document archival system
• Experience in an industrial company, utilizing SolidWorks EPDM or similar
• Experience working with PDM tools
• Must have working experience with Microsoft Office products (Excel, Word, PowerPoint)
• Excellent written and verbal communication skills with excellent presentation skills before small groups
• Outstanding organization, analytical, and problem-solving skills
• ERP/MRP experience, within a Document Control Position
• Experience with Document Database systems (Aspire, eFileCabinet, FoxPro, FileMaker Pro, Microsoft Access, etc.)
• Ability to train staff in Document Control Processes, use of controlled documents, and archival servers and folders

Qualifications: BA in Business Administration with 5 years of Experience

• GMP laboratory and documentation experience
• Experience working in scientific-technical writing
• The ability to work within the PPL safety guidelines.
• Good written and oral communication skills, ability to communicate effectively, and project a professional image when giving and taking information in writing, in person, and over the phone.
• Accurate typing/keyboarding skills, with solid computer skills, including the use of word processing and spreadsheet software applications.
• Ability to take initiative and prioritize tasks, good time management, problem prevention, and problem-solving skills.
• A good working knowledge of cGMP, specifically, ICH Q7.
• Sufficient technical background and understanding to review Production Batch Records and other GMP documents.
• Ability to work independently and as part of a team, and ability to motivate self. 
• Ability to work accurately with close attention to detail, and maintain confidentiality of sensitive information.
• Ability to work with co-workers, customers/clients, and outside agencies professionally and tactfully.

Qualifications: BA in Supply Chain Management with 2 years of Experience