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Technical Writer

Location:
California, United States
Posted:
February 15, 2018

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MADELINE POPA

E-mail: ac4hnf@r.postjobfree.com Cell: 909-***-**** https://www.linkedin.com/in/madeline-m-popa-8b5156a1/

SENIOR TECHNICAL WRITER

Highly skilled Technical Writer with extensive experience in the biotech, pharmaceutical and medical device industries. Expertise in centralized document management, change management, and regulatory requirements. Excellent writing and presentation skills, with ability to analyze and interpret complex data. Strong interpersonal and problem-solving skills; highly effective at building rapport and coalitions across functions and within multi-cultural environments. Core competencies include:

USP/NF/BP/EP Compendial Requirements

Project Management

Quality Control

GMP Compliance (including CAPA)

Database Management

Press Releases

Scheduling and Meeting Coordination

Grant Proposals

Event Support

Desktop Publishing

PROFESSIONAL EXPERIENCE

PEREGRINE PHARMACEUTICALS, Tustin, CA (August 2016 – October 2017)

Scientific Writer (Process Sciences)

Responsible for helping prepare and issue reports based on the studies conducted by the scientific staff in the Process Sciences Department

-Prepared (writing, editing, indexing, bookmarking, creating and inserting tables and figures, etc.) technical data summaries, project reports, upstream and downstream process development studies.

JOHNSON & JOHNSON MEDICAL DEVICES, Irvine, CA (July 2015 – July 2016 )

Technical Writer (Contract) – Cardiovascular & Specialty Solutions (CSS Group)/ Quality Systems

Responsible for writing/reviewing documentation and coordinating successful document approval through the Change Control process

-Wrote, reviewed, edited, and updated documentation such as: procedures (including business process mapping appendices), work instructions, forms, templates, customer letters, and other documents for ASP (Advanced Sterilization Products), Acclarent, and Mentor.

-Processed CO/ECO requests in Oracle-based system (EZDOC) and Arena PLM using document version control procedures.

SELF-EMPLOYED – (January – December 2014)

Content Writer - Wrote short stories, poems, political essays; created/edited private documents; occasional blogging.

ACTAVIS/ALLERGAN (formerly Watson Pharmaceuticals Inc.), Corona, CA

Project Coordinator (Contract) – Manufacturing (June – October 2013)

-Managed change control requests and updated SOPs per CAPA solutions/procedural modification compliance (e.g., gowning and de-gowning sequence for production workers).

-Created new SOPs (by combining information from technical manuals, SME-recommended procedural flow, and hands-on research) to address the integration of new equipment and software into the manufacturing process (e.g., software sequence instructions for blister-packaging equipment operators).

-Reviewed and edited technical documentation for content, grammar, punctuation, and format consistency.

Technical Writer – Research & Development Analytical (July 2007 – July 2011)

-Developed cGMP documentation:

Wrote, reviewed, and edited analytical methods, certificates of analysis, validation protocols and reports.

Created new documents and updated existing ones by integrating pharmacopoeia-researched information, laboratory data, and graphics/images from LIMS/CDS interface.

-Reviewed QbR documentation (eCTD format) for ANDA filings.

-Acted as gatekeeper in document change management system by approving, rejecting or re-writing documentation, and guiding requestors in navigating the approval process using version control.

-Reviewed laboratory logs and batch records for accuracy and procedure compliance.

-Successfully completed requests from multiple departments for document analysis and technical writing support.

-Prepared documentation for internal and external audits (FDA).

Department Coordinator II (Contract) – Corporate Quality Assurance (June 2006 – May 2007)

-Supported R&D and QA document migration into FDA-validated computer system (Livelink EDMS).

-Actively participated in the design of controlled documentation templates.

-Reviewed and edited documents for content, grammar, format, and data accuracy.

-Executed functions of Change Manager and Workflow Manager (EDMS) for controlled document review, approval, and archival processes.

-Wrote guidelines for QA department for the functions of Change/Workflow Manager (step-by-step simplified instructions for clarity and improved efficiency); used extensive EDMS-software knowledge to troubleshoot workflow problems, identify solutions, and provide technical support to end-users.

SAN BERNARDINO COUNTY PROBATION DEPARTMENT/Fiscal Division (Contract) (January – May 2005)

Fiscal Clerk II

-Maintained memoranda, updated database, created invoices, ran queries and created reports, and performed other administrative/clerical duties as assigned.

PATHOLOGY MEDICAL SERVICES, Lincoln, NE (May 2002 – June 2003)

Medical Secretary

-Interpreted, transcribed, and edited clinical pathology reports; created daily production reports; ensured compliance with HIPAA regulations (45 CFR 164).

OCIA INTERNATIONAL INC., Lincoln, NE (January 2001 – February 2002)

Program Coordinator/Certification Specialist – JAS (Japan Agricultural Standards)

-Coordinated organic certification program for exporting agricultural products to Japan by U.S. and international businesses:

Issued JAS certificates based on verification of compliance (the “JAS seal”)

Verified eligibility requirements for submitting parties; reviewed submitted documentation for compliance with MAFF-JAS (Japan)/NOP (U.S.) regulations and certifying company standards.

Researched technical data and monitored legal aspects of the certification process, including compiling information pertaining to relevant changes in the USDA, MAFF, IOAS, and EU-accreditation programs.

Coordinated flow of confidential and time-sensitive information and documentation with corresponding office in Tokyo, Japan.

Created tracking system/database for the JAS program and provided JAS program training to staff.

TRAINING

Advanced functionality of all Microsoft applications

Regulatory compliance training

Principles in Leadership (Watson Pharm.)

Organic Certification and Accreditation

Content and document management systems

Group Challenge and CIRCLE Project (UNL Professional Programs)

Website development and design

HTML, JAVA (Level I)

Software Programs:

Microsoft Office Suite (Word, Excel, Access, PowerPoint, Outlook, InfoPath, Publisher, SharePoint); Microsoft Visio; WordPerfect Office Suite (WordPerfect, Quattro Pro, Paradox, Presentations); Adobe (Acrobat, PageMaker; Freehand; Illustrator; Photoshop; InDesign); ClarisWorks; CorelDraw; Lotus Notes; Scheduler Plus (CEO); CoPath Plus; MAS 90 (Sage 100 ERP); GoldMine CRM; Quicken; ISI Writer; TrackWise; Livelink ECM (Open Text); EZDOC (Oracle Database); Arena PLM, Siebel CRM

EDUCATION

College/

University

Majors: Biology (Pre-Medical) and History (U.S. and European)

Union College, Lincoln, Nebraska

University of Nebraska-Lincoln

Other

The School of Music and Fine Arts, Bucharest, Romania

Completed studies in: Music Theory, Musical Composition, Piano

Larabee School of Real Estate (Lincoln, NE)/ Randall School of Real Estate (Omaha, NE)

Completed courses in: Principles and Practices, Finance, Appraisal, Property Management, Law, Sales and Brokerage

LANGUAGES

English, Romanian, French



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