Shelley T. Obilam

Technical Writer/Document Control

215-***-**** / adulq8@r.postjobfree.com

Numerous years in the biotechnology and pharmaceutical industry with significant experience in compliance, technical writing, batch records and documentation. Proficient in Microsoft, Documentum and others. Excellent communication, administration and presentation skills. Proven skills in meeting deadlines. EDUCATION:

Beaver College (Arcadia University), Glenside, Pennsylvania Bachelor of Arts

Major: Biological Sciences

SUMMARY OF SKILLS:

Documentation Skills

• Document formatting

• Proofreading

• Electronic Document Management System

(EDMS)

• Technical writing and editing services

• Certificate of Analysis (COA) and Certificate

of Compliance (COC)

• Summary Documents

• Document filing

• Current Good Manufacturing Practices (cGMP)

Technical Writing Skills

• Creating and writing Standard Operating

Procedures (SOP)

• Documentation filing and revision of SOP’s

• Batch Record and upgrades

• Standard Manufacturing Procedure (SMP)

• Specifications

• Deviations

• Investigations

• Root Causes

• Trend Data

• Validation protocols/Validation Master Plan

• Primary and Secondary Rooms qualification

• Auditing and writing for Production packaging

• Adverse Event

• Report Writing

• Stability Reports

Laboratory Information Management System (LIMS) and Laboratory Skills

• Sample Manager LIMS

• SQL LIMS

• Perkin Elmer LIMS

• Watson LIMS

• Template Development

• HPLC, GC, UV, FTIR, AA, ICP, raw materials,

bulk, finished products, stability and retain

samples; EP, JP, and USP

• Process validation and cleaning validation

Investigational Skills

• Deviation Investigations

• Customer Complaints

• Corrective and Preventive Action (CAPA)

• Investigation Reports

• Change Controls

Auditing Skills

• Reviewed laboratory notebooks/instruments

• Inspections

• Audited packaging lines

• Assisted mock audits

Training Skills

• Developed training material

• Provided training to new employees and

refresher training to employees

• Assisted in Job Aids

• Lecture, audio, video and teleconference

communications set up and skills

Computer Related Skills

• Microsoft Office 2007 and 2010

• Adobe Acrobat

• Excel

• Microsoft Teams and Zoom

• EDMS, TDMS, eDOC, Documentum, QUMAS

• SharePoint

• TrackWise

• MasterControl

PROFESSIONAL EXPERIENCE:

Catalent Pharma Solutions, Harmans, MD October 2019 to December 2022 MANUFACTURING TECHNICAL SPECIALIST/TECHNICAL WRITER

• Standard Operating Procedure writing and revisions

• Standard Manufacturing Procedure revisions

• Batch record revisions

• Specification revisions

• CAPA’s and Change Controls

• Master Control and Track Wise

Almac Group, Souderton, PA April 2018 to February 2019 Analytical Sciences

DATA AND DOCUMENT REVIEWER (contract work)

• Ensured all raw data and associated documentation generated in the laboratory was accurate and in-line with Almac Sciences procedures and culture of Right-First-Time

• Received on-going training and updates

• Assisted the QA manager in fostering a culture of quality improvement

• Analytical documentation and cGMP

• Empower usage

Eurofins Lancaster Laboratories, Malvern, PA July 2016 to April 2018 Product Development

TECHNICAL WRITER/DOCUMENT CONTROL (contract work)

• Document Management

• SOP writing and revisions

• Specification writing and revisions

• Risk Assessments

• Bill of Materials/Raw Materials

• Change Controls

• TrackWise

Medical Products Laboratories, Philadelphia, PA June 2014 to February 2016 Quality Control

TECHNICAL WRITER (company lay-offs)

• Issuance of Certificate of Analysis (COA) and Certificate of Compliance (COC)

• Document filing and document review

• Stability Protocol writing

• Expiry Term Memo writing

• Change Controls

• Laboratory specifications creation and update

• Analytical methods update

• Raw Materials

Various Publishers, Philadelphia, PA July 2013 to Present FREELANCE WRITER (self-employed)

• Article writing

• Proofreading

• Literature and Research

• Procedure/Instruction Writing

• Logos/pictures/graphics inserts

• Language and formatting

Transcat, Lancaster, Pennsylvania December 2012 to June 2013 Calibration Services

DOCUMENTATION SPECIALIST (contract work)

• Mastery of the life cycle of documents

• Technical documentation of Standard Operating Procedures, Master Batch Records and protocols

• Metrics

• Spreadsheet data formulation and presentation

• Laboratory and Microbiology equipment and instrument review

• Packaging equipment review

• Commissioning and decommissioning review

• Flow diagrams for various documents

AstraZeneca Pharmaceuticals, Newark, Delaware July 2011 to December 2012 Compliance Services

TECHNICAL DOCUMENTATION ANALYST (contract work)

• Batch Records and Standard Operating Procedures with pertinent attachments

• Mastery of the life cycle of documents

• Assigned effective version of controlled documents

• Handled, processed and close out of Document Change Requests

• Created required controlled documents

• Obsoleted required controlled documents

• Distribution of draft documents

• Editing of controlled documents

• Visio flow diagrams for Standard Operating Procedures

• LMS usage

Nutramax Laboratories, Edgewood, Maryland November 2010 to July 2011 Quality Assurance, Packaging and Manufacturing Plant relocation TECHNICAL WRITER (contract work)

• Technical writing in Standard Operating Procedures, batch records, protocols and documents

• Performed deviations, investigations, CAPA’s and change controls for products.

• Assisted in packaging and manufacturing of products

• Packaging SOP review and writing

• Responsible for handling customer complaints

• Created Excel spreadsheets for tracking and analysis Pfizer, Collegeville, Pennsylvania October 2009 to March 2010 Nutrition Quality Operations

DOCUMENTATION SPECIALIST (contract work)

• Required to create, review, edit, and issue technical documents including Purchase Specifications/Testing Standards for the raw materials for the priority SAP project. Review compendial changes, supplier’s Certificate of Analysis (C of A) and any other supporting documents to create/edit specifications

• Maintained periodic review of the documents

• Utilized GMP experience to ensure completeness, accuracy, and compliance of the documents

• Identified issues and complied with Standard Operating Procedures and associated job aids. Maintained a tracking system for the review and approval of specifications

• Updated tracking system daily for documents during drafting, approval, and completion process

• Coordinated review and approval process from the early commentary stage through the final approval stage

• Maintained files and completed detailed project work as assigned

• Created a workflow and lines of communication between departments and sites when documents were reviewed and approved

• Devised plan and execution to maximize record keeping to help accelerate delivery of documents to sites.

• Handled urgent and critical requests within a timely manner

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