Document Control Change

Randy K. In

adz041@r.postjobfree.com

OBJECTIVE:

Result-oriented professional individual with over 20 years of experience of Document Control and Records Control in the Medical Device, Biotechnology, and Pharmaceutical industries. Highly Knowledgeable and analytical Documentation Specialist has excellent attention to detail and strong organizational skills. Has good understanding of confidentiality rules and appropriate filing systems. My professional objective is to be a positive addition to your organization, striving as a proven team player to help your organization be the best it can be.

SKILLS:

*SAP-LMS

*Made2Manage EDMS

*Agile EDMS

*eDocS EDMS

*NovaManage EDMS

*TeamCenter

*Cisco Certified Network Associate (CCNA)

*Documentum

*GXP Documentation

* ISO 9002, ISO 13485/EN 46000, ISO 13488/EN 46002 standards and FDA related regulations

* Proficient in computer software programs (e.g., MS Word, Excel, Access, Visio, etc.)

EXPERIENCE:

Illumina Inc, San Diego, CA (4/2017 to 8/2023)

Document Control Specialist

Summary of Duties:

Administration of the records management system consists of providing reliable record services and protect records. Operate best practice in relation to information and records management to ensure (among other things) that administration of the records management system is more efficient as information is easier to find, is reliable, is secure. Manage documents change control to support manufacturing in compliance with ISO 13485, GMPs, and FDA guidelines.

*Lead Records Management Program at the San Diego Headquarter

*Provide guidance and training to staff members, contractors, Document Owners, and Record Owners

*Help team resolve Document Change Order (DCO) issues with users

*Perform document master data verification in SAP-PLM system

*Lead and resolve records inventory management issues

*Drive/Lead process decisions

*Troubleshoot and resolve complex issues

Thermo Fisher Scientific, Carlsbad, CA (4/2011 to 3/2017)

Lead, QA Document Change Control Analyst

• Responsible for the development, implementation, coordination, maintenance, and security of controlled documents to ensure process and product related documentation meets operational needs and conforms to company standards as part of the change control process. The change control process encompasses changes in documentation, labels, equipment, specifications, software and test methods. Coordinating the implementation and documentation of changes with manufacturing engineering, R&D, purchasing, facilities, etc.

• Administered document change control system consists of initiating and tracking all incoming, in-process and completed change requests, tracking all associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out.

• Maintained document control system consisting of product related documentation, drawings, quality manuals, CoA’s, CoO, CoC, product/process software, external documentation, validation reports, R&D laboratory notebooks, NPI files, production documents for the Legal department, training records, quality internal and external audit reports and department procedures and work instructions.

• Collaborated with line management in the formatting and generation of documents that reflect their manufacturing processes and conform to the requirements of the document system. Confer with document originators to resolve discrepancies and update procedures.

• Provided guidance and training to junior staff members, contractors, and the Change Author community, identifying and supporting continuous improvements of the Process for Managing Change and leading Document Control department.

• Provided reports and metrics on the Change Process and participate in both external and internal audits.

• Conformed to ISO 9001 standards and FDA regulations

GenMark Diagnostics, Inc., Carlsbad, CA (1/2011 to 4/2011)

QA Documentation Specialist

• Change Administration – Screens Document Change Orders (DCOs) for completeness and accuracy. Prepares DCO packets for review, tracks DCOs through the review and approval process and coordinates incorporation of approved changes.

• Worked with originators and approvers to ensure company timelines are met; tracking at all stages of routing, approval, distribution, periodic review and storage of history files, maintenance of documentation and filing of all master documents.

• Examined documents to verify compliance, completeness and accuracy of data and confer with document originator and approvers to resolve discrepancies. Compile required changes to documents.

• Conformed to FDA regulations

Life Technologies Corp. (formerly Invitrogen), Carlsbad, CA (2009 to 8/2010)

QA Document Control Specialist

• Responsible for completing change requests, tracking all associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out. Using Agile eDMS

• Ensured that documents are revised and processed in a timely manner, according to the change control process and department processing time goals.

• Processed all documents and perform administrative clerical checking for accuracy and completeness and release to the authorized users. Collaborate with line management in the formatting and generation of documents that reflect their manufacturing processes and conform to the requirements of the document system.

• Conformed to ISO 9001 and FDA regulations

Merck (formerly Sigma-Aldrich), Carlsbad, CA (10/2007 to 2009)

QA Specialist

• Performed all duties associated with document control, including creation of new documents, revise existing documents, obsolete outdated documents, and ensure that all documents are handled in a controlled manner. Using eDocS eDMS.

• Managed document change process, which includes issuing numbers, circulating for review and approval; tracking at all stages of routing, distribution, storage of history files and periodic review, maintenance of documentation and filling of all master documents.

• Provided customer service to all employees needing assistance with controlled documentation (e.g., Standard Operating Procedures (SOPs), Batch Records (BRs), Item Specifications, and etc.)

• Maintained binders of controlled documents throughout production and laboratory facilities.

• Conformed to FDA regulations

Roche (formerly Genentech), Oceanside, CA (8/2005 to 9/2007)

QA Documentation Specialist

Worked with all document owners/originators across the site to ensure that all documents are complete, accurate and in compliance with established quality standards, policies, and practices. (NovaManage EDMS)

Examined documents to verify compliance, completeness and accuracy of data and confer with document originator and approvers to resolve discrepancies. Compile required changes to documents.

Prepared, edited and formatted various documentation (e.g. GMP, GLP, GCP)

Managed all aspects of document conversion process.

Maintained Training Records, to assure specific training is provided and documented.

Provided documentation support on all released documents (e.g. user inquiry, report, listing, etc).

Liaison between all departments in managing periodic review of documents.

Tracked and filed employee training records and other GMP documents.

Received Recognition Award for Extraordinary Productivity, 8/15/2006

Biogen Inc., San Diego, CA (6/2002 to 8/2005)

QA Documentation

• Managed and implemented DCO (Document Change Order) packages; compiled and maintained control records and related files to release documents to manufacturing and other operating departments; updated master documents and indexes to reflect approved changes.

• Prepared and reviewed DCO packages, assigned DCO numbers, tracked open DCOs and maintained document control files (paper base and electronic documentation system). Using eDocS eDMS.

• Handled Document Control issues associated with maintaining and controlling current documentation, assigning part numbers for parts and controlled documents then entering Item Master Requests (IM).

• Ensured that documentation is written, edited, reviewed and approved in a timely manner to meet established deadlines.

• Conformed to FDA regulations

Received Special Recognition Award for Productivity, 6/2003

Avail Medical Products, Inc., San Diego, CA (10/2001 to 6/2002)

QA Document Control

• Involved in efforts to bring company in compliance with ISO 9002, ISO 13485/EN 46000, ISO 13488/EN 46002 standards as well as FDA related guidelines.

• Performed modification and construction of complex tables in both Word and Excel, executed mail merges, inserted and manipulated pictures/graphs, worked with frames, text flow, style sheets and links between worksheets.

• Assigned document numbers; updated and maintained of the Electronic Document Management System. Using Made2Manage EDMS.

• Responsible for interfacing between engineering and manufacturing to ensure appropriate documentation of changes.

EDUCATION:

Documentation - Meeting Regulatory Expectations, Center for Continuous Education, San Diego, 2003

Cisco Certified Network Associate (CCNA), Cisco Academy, 2002

MBA in International Business Administration, Alliant International University, San Diego, CA, June 1996

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