SUMMARY

• Documentation professional with strong written, oral, and interpersonal communication skills and diverse/well rounded experience in a Document Control/Technical Writing function primarily within the regulated pharmaceutical and medical device industries.
• I have demonstrated a high level of comfort and success at taking the lead and being accountable for the management of documentation and related processes.
• Readily adapt to changes in work processes and procedures while prioritizing tasks without compromising project deadlines. Further, I am able to maintain a high degree of accuracy when expediting tasks/projects as necessary to meet shifting departmental and company objectives.
• I have demonstrated the ability to competently self - manage while effectively supporting and training/coaching others.
• I have earned the recognition and respect of my peers and management as a true team player by willingly assisting in areas outside the scope of my specific job function (e.g., assisting in packaging of stability samples in support of new product approval process and assisting in equipment and material transfers in support of equipment validation).

PROFESSIONAL EXPERIENCE

Document Specialist, Senior

Confidential, Ridgefield, NJ

Responsibilities:

• Proofread / perform quality check of documents for proper format, grammar, and completeness (e.g., revision history accurately captures revisions with applicable rationale for change) prior to routing for approval.
• Responsible for the issuance/printing, tracking, retrieval, reconciliation of Batch Production Records (BPRs) and Bill on Materials (BOMs), which includes performing data entry in MS Access and MS Excel databases.
• Manages the logbook process (creation, printing, binding, distribution, tracking, retrieval, and archival).
• Issue protocol and report numbers within Infolinx database to ensure items in the QA DMG vault are uniquely identified via a distinct document number and Infolinx generated barcode.
• Maintain the onsite central vault of various original/official CGMP documents.
• Responsible for the offsite archiving of documents at Iron Mountain in accordance with corporate standard retention policies.
• Assist in the preparation, routing, and tracking the approval process for labeling documentation (i.e., Information for Use (IFUs), component specification, and engineering drawings).
• Scan and upload drawing and labeling files to Livelink EDMS.
• Support regulatory audits by manning Genzyme’s audit readiness room to fulfill auditor requests for documentation.
• Tracked/provided monthly metrics/updates regarding the site objective for Smart SOP format conversions to QA Manager and Director Compliance for reporting to Ridgefield’s Site Director.
• A metric that affected the bonus payout for all site employees.

Documentation Specialist/Technical Writer

Confidential, Pearl River, NY

Responsibilities:

• Perform walk-through review of manufacturing processes to ensure accuracy between daily practice and the current written procedure(s)/SOPs/BPRs.
• Perform all Document Coordinator/Business Administrator activities for documents through the GXPharma lifecycle from initiation to issuance for use and/or to being made obsolete/retired.
• Facilitate Sandbox Training Sessions to Pearl River Site GXPharma users to familiarize them with the system.
• Act as runner during Regulatory Audits to retrieve and provide documents requested by auditors to the Site Readiness team.
• Created a checklist/guide for the group to ensure consistency of format and content across departmental SOPs.
• Stepped in to manage the group’s overdue/Consent Decree SOP obligations in Supervisor’s extended absence including scheduling workload, assimilating a new writer, providing project status updates to management, and representing the group at meetings.

Documentation Specialist

Confidential, Pearl River, NY

Responsibilities:

• Input and route documents in EDMS R and GXPharma.
• Assisted with general document formatting issues.
• Provided group and one-on-one training on the use of EDMS R and Various Document Templates.

Technical Writer

Confidential, Pearl River, NY

Responsibilities:

• Responsible for issuance, tracking, and retrieval of SOPs, Monographs, and training protocols within the QC labs.
• Created templates for method validation and cleaning validation protocols and reports.
• Assisted in the approval process by working to clarify and resolve issues and concerns regarding documents.
• Stepped up and filled the role of Document Control Coordinator (DCC) following staff departure and a budgetary decision not to replace the head count all while continuing to fulfill primary/direct job function as Technical Writer.

Sr. Documentation Control Coordinator/Technical Writer

Confidential, Mahwah, NJ

Responsibilities:

• Generated SOPs and other necessary documents as a member of the Quality Systems department. Proofread SOPs, Specification Sheets, Manufacturing Instructions, QC Documents, Cleaning Procedures, Protocols, Reports, etc. to ensure completeness, readability, and clarity and compliance with cGMP / QSR, ISO, and internal Quality System guidelines and regulations.
• Issued and updated the divisional QSM (Quality Systems Manual) under the direction of the Director, Global Quality.
• Decreased the time required to obtain ECN approval from approximately 39 to 14 days by implementing and organizing multi-site ECN sign-off meetings and actively enforcing adherence to specified review/approval deadlines.
• Appointed by the Division President to the Design Control Continuous Quality Improvement (CQI) team to assist in improving the division's R&D documentation system and structure in order to close out open audit observations.
• Played a critical role by facilitating the revision and creation of documentation required for Mahwah manufacturing facility approval and startup.
• Served as an Internal Quality Auditor.

Technical Assistant Research & Development/Groupware Specialist

Confidential, Pearl River, NY

Responsibilities:

• Recorded notes of Architecture Review Board (ARB) meetings and performed updates of technical programming specifications based upon notes recorded during ARB meetings.
• Posted specification updates and meeting minutes to Confidential ’s WEB page using Lotus Notes for access by subscribing member organizations.

Documentation Administrator

Confidential, Chestnut Ridge, NY

Responsibilities:

• Wrote procedures and produced flow process diagrams documenting the Engineering Services department practices in preparation for obtaining ISO certification.
• Assisted Marketing in the creation/writing of a user’s guide for shipment with Disk Drive Failure Analysis product.