Document Control Engineering
Resume:
Connie Marie Lemken
Professional Summary
I possess 25 years of experience as a Document Control Analyst. I work well in a team driven atmosphere and I am flexible to changing environments. I possess a strong work ethic and a desire for exceptional results. I believe my background uniquely qualifies me to become an integral and valuable member of any team. I have the ability to work independently and creatively with the maturity necessary to complete high-pressured jobs correctly and on time. Good understanding of Document Control requirements and processes. I am interested in utilizing theses strong skills in a challenging and rewarding career opportunity with successful and diversified organization.
Work Experience
Sandel Avionics, Inc., Vista Ca 1/11/17-7-24-17
Sr. Document Control Specialist/Auditor AS9100
AVIATION
Perform AS9100 Internal Audits to ensure the process effectiveness and Quality Management System Compliance. Generated Audit reports and metrics for Audits.
Tracked and close audit findings and generated metrics for external audits. Maintained Equipment Calibration.
Managed and implemented all Action Request for changes. Created new part numbers and maintained Bill of Materials (BOM’s).
Updated QMS per AS9100 REV D.
Auditor for the Sandal repair station at Mcclellan Palomar Airport Hanger (FAA Approved repair station).
Analyze data to identify areas for improvement in the QMS.
Maintained all TSO/STC books.
Establishes and maintains procedures for storage, retention and destruction of company records.
Alphatec Spine Carlsbad, CA 06/2016 –11/2016
Document Control Analyst/Auditor/Purchasing
SPINAL FUSION TECHNOLOGIES
Agile PLM and EDMS System and responsible for ensuring the review, approval, creation, revision, obsolescence, and implementation of Quality System Documentation is completed and in compliance with the Document Control polices and procedures.
Documents and updates policies and standard operating procedures to ensure regulatory compliance with standards, guidelines and regulations (21 CFR 820 QSR, ISO 13485, CMDCAS, MDD and CE). Responsible for scanning all the received Work Orders in Vantage, run a status report, and notify responsible departments of Work Orders that indicate are closed but have been submitted for filing.
Controlled and maintain the document index list in Excel for all employees training records.
Working with Tabulated drawings files in Agile. Reviewing all incoming ECO’s and Deviations through Agile and moving them to CCB. Performing duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
Document internal audits and other quality assurance activities.
Approval status updating the Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs) and Deviations for final release and implemented.
Responsible for all CO’s rejections (count) for end of month report. Monitor ECO’s through Electronic Data Management Systems (EDMS).
Flux Power, Vista, Ca 5/2015 – 2/2016
Document Control Analyst /Purchasing
ADVANCED LITHIUM BATTERY PACKS
Document Control Specialist is responsible for project managing, the process of change control.
Updating all BOM’s structures and new procedures for Document control ECO processes.
Participates in analyzing and reviewing changes with engineering, quality assurance and manufacturing to determine overall effect of changes on product or system and to ensure compliance with customer requirements and Company policy. Familiarity with good documentation practices, filing, imaging technology, engineering drawings, specifications and bill of materials.
Breg, Carlsbad, California 10/2014 –5/2015
Document Control Analyst
BRACING AND COLD THERAPY
Document Control Specialist is responsible for administering the Quality System controlled documents in accordance with Breg’s policies and procedures and FDA regulatory requirements (ISO 13485, and FDA CFR Title 21 Part 820).
Administration of SAP ECOs and the document change control process including the review of Documentation, Materials, and BOM Structures for completeness and correctness as well as Change Notice submissions for acceptability prior to signature routing as you ensure proper distribution and retrieval of controlled documents. Ensure training requirements are addressed and documented when required.
Release Engineering Change Orders (ECOs) by ensuring the request meets the Change Control policies, procedures and regulation standards.
Coordinate and perform training for all new employees and users on the change control process as required. Coordinate returns to supplier utilizing Non-Conforming Material Report procedure and MRA form.
Responsible for maintaining the Engineering Change Order log from start to release and develop monthly measurement to be used for process improvements.
Facilitate the Change Control Board.
Generate notifications to the appropriate process owners and authors on new or revised documents.
Act as the liaison between Mexicali and Vista on shared activities.
Assist in internal process development focused on streamlining Change Order efficiency and effectiveness through continuous improvement tools.
Lead effective team meetings and document results.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Configuration Control Essential Duties: Perform data entries to Bill of Materials, Item Master, and Change Orders..
Essential Duties: Responsible for creating and updating the Standard Operating Procedures (SOP) and forms, and ensuring the SOPs conform to established document formats and applicable standards. Maintain the employee training records, department matrixes and enter the information into the Train Track database.
Participates in analyzing and reviewing changes with engineering, quality assurance and manufacturing to determine overall effect of changes on product or system and to ensure compliance with customer requirements and Company policy.
ViaSat, Carlsbad, California 2/4/2013 – 4/29/2014
Document Control Analyst/Government Contracts
SATALITE COMMUNICATIONS
Responsible for multiple government programs and Contracts (secret clearance).
The task was to document and track all ECR’s, ECO’s Deviations in Agile/Java. Review Change orders for completeness, accuracy and assess impact to other document and Agile PDM.
Proof reading of government contracts.
Responsible for logging, filing, and tracking all necessary drawings, documents, travelers, CDRL’s and government contracts in Agile.
Support Library Assessment for the entire company.
Compile and summarize data to use in preparing special reports maintain data deliverable schedules, and post data items to customer websites and generation/editing, completion, processing, and release of documents, change orders, change proposals, and data packages.
Became a super user in the corporate Product Lifecycle Management (Oracle/Agile) tool.
Linear LLC, Carlsbad, California 01/5/2005 – 1/5/2013
Document Control Analyst/Lead role
SECURITY AND CONTROL PANELS/GARAGE DOORS
Responsible for documenting and tracking all new/existing documents in the Maxcim database, and all aspects of ECO’s (engineering Change Orders). Linear uses a Manufacturing Resource Planning (MRP) program called Maxcim which stores part numbers in a database.
These part numbers are controlled and maintained by Document Control changes to established master files of contractually requires technical data.
Responsible for generation/editing, completion, and release of documents, engineering change orders ECR’s and Deviation change proposals and data packages.
Responsible for logging, filing and tracking all necessary drawings, documents, barcode labels, software and commercial part approval form and the supporting vendor’s data sheet which allows an entry of component into the Approved Vendor List (AVL).
Back up for the component engineers. Responsible for maintaining data deliverable schedule, and post data items to customers via email (Microsoft Outlook).
Implemented SOP procedures and maintain close relationships with vendors and our Manufacturing staff in Linear Hong Kong.
Dj Orthopedics, LLC, Vista, California 06/1997 – 11/2005
Document Control Analyst
BRACING AND SUPPORT/CUSTOM BRACIN G FOR ATHELETES
Review, analyzes and verify with the new/existing release of documentation in accordance with SOPs.
Ensure requirements of initiator/requester of the Change Orders are met. Coordinate and maintain new and existing part number issuance.
Update master database, Coordinate with purchasing, engineering and vendors on drawings and follow up status on lead-time.
Communicate change order information and interface with engineering organizations. (Manufacturing Engineering and Design Engineering), Managers, Manufacturing, Purchasing, Production, Planning, Quality, Marketing/Sales, Customer Service and Office Care.
Coordinate new project designs with engineering, manufacturing and marketing. Maintain routing and review all multi-level Bill of Materials and labels.
Support compliance departments during regulatory inspections/audits/calibration. Maintain Device Master and Device History Records.
Maintain document control records and prepare document packages for routing signatures and manufacturing labels (translations in 5 different languages).
Trained employees on GMPs, SOP’s and FDA laws.
Administer training for new procedures to documentation changes/deviations. Manager calendar set up for meetings and ordered office supplies.
Manage Product Rationalization Program with sales department.
Maintain latex information on new products.
Prepare and maintained all packaging and labeling for new and existing products.
Block Medical, Carlsbad, California 05/1991 – 05/1997
Document Control Analyst/QA Inspector Specialist
HOME PUMP INFUSION
Coordinated and maintained all new part number issuance for new and existing products.
Release change orders by ensuring the request meets the change control policies, procedures and regulation standards.
Managed preparation of documentation closure of regulatory commitments, contracts and submissions.
Developed systems to ensure effective, timely document reconciliation including, SOPs, Controlled Forms, deviations, Device Master and History Records and Technical Files. Experience with 21 CFR 820, ISO 13485.
Trained new employees on the ECO processes of CAPA – Corrective and Preventive Action. Label and packaging on all incoming SOP’s in clean room environment. Review and disposition of batch records.
Monitor ECO’s through Electronic Data Management Systems (EDMS).
Hughes Aircraft, Carlsbad, California 02/1983 – 04/1991
Document Control Specialist/Purchasing
DEFENSE MILITARY CONTRACTS
Maintained documentation control and highly confidential intellectual property data/ files, Government secret clearance.
Preparation and review of all multi-level bills of materials.
Familiarity with good documentation practices, filing, imaging technology, engineering drawings, specifications and bill of materials. Responsible for obsolescence/history of part numbers in a database system.
Worked independently, problem solves and carried out diversified tasks in the best interest of the Vice President/Managers/Engineering & Operations.
Supervised cross-functional training for new products and contracts and Maintained document control records, prepared document packages for routing and approvals and maintained Device Master and Device History Records.
Attended training classes on documentation, ISO and cGMPs.
Maintained all new product labeling and translations.
Trained employees on cGMPs and SOPs.
Technical Skills:
Proficient with Microsoft office applications
DocStar Electronic record storage/retrieval
Bartender Label Program
Highly computer literate
60 wpm, 10 key by touch
Strong organizational and communication skills
Highly organized
Strong written, verbal, problem solving/decision making and analytical skills
Training Classes:
8 years experience applying quality system regulations and standards, including 21 CFR Part 820 (cGMP), ISO 13485, ISO 9001
Good working knowledge of ERP/MRP systems
Experience SAP/Agile PLM
AS9100 Auditor
Experience with delivering training material to groups
ViaSat University Microsoft word/excel
2 Secret Clearance (Viasat and Hughes Aircraft)
Siemens Teamcenter ERP
Bartender (GTIN/UDI labels)
QC experience in an FDA regulated environment
Experience with maintaining and administrating an EDMS (Electronic Data Management System).
Working on getting my APICS Certification
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