Document Control Quality Specialist

Tom Spolar

***********@*****.*** Cell: 224-***-**** San Marcos, CA

SKILLS

Agile PLM

TrackWise

PowerBI

Adobe Analytics

AEM

Microsoft Office

Advanced Excel

IBM Unica

EDUCATION

HBS Club of San Diego Not-For-Profit MDP Certificate Winter 2019

The University of Illinois at Chicago

B.S. Degree – Major: Marketing – Minor: Business Analytics

PROFESSIONAL EXPERIENCE

Genentech - Oceanside CA August 2022 – June 2025

Sr. Document Control / Quality Specialist

Review and approve quality documents, SOP batch records and technical records

Assist in the preparation of regulatory submissions including detailed review of data and reports to ensure alignment within project structured organization.

Process changes orders and maintain documentation workflow including drafting, redlining and finalizing

Lead assist in project planning including trend analysis and reports to quality initiatives

Maintain document control compliance aligned with corporate standards and regulatory requirements

Provide training and support to team members on SOP and document control systems and practices

Assist in internal investigation and external audits by promptly retrieving GMP/GLP retrieving documents needed for investigations or audits – maintain in state of document inspection readiness

Review and proofread existing product labels against reference labels for conformity and specify changes

Perform management quality of the product documentation – labeling accuracy

Quality documentation associated with the labeling change control process that meets regulatory requirements

Contribute to oversee policies, procedures and compliances related to document control, records retention, batch records management – manage Team training and CAPA management system

Ensure compliance with FDA /ISO and industry regulations.

Issuing and modifying document and drawing number in SharePoint Master Control Document Lists

Analyze changes to the Bill of Materials (BOM’s) and integrate all changes into electronic data management like Master Control or ERP systems – Audit documents and change and change control files.

Support implementation and oversight of key quality systems such as Deviations and Complaints

Collaborate with Site Operation’s SME’s and Technical assessor for document creations and revisions.

Thermo Fisher Scientific – San Diego, CA July 2021 – March 2022

Document Control Analyst (Contractor) – Bioscience Division

Update product documentation with updated health, safety, warnings, etc. info to allow release of products, so they can be filled, packaged, and shipped out to the customer. Releasing 100,000+ dollars in back orders.

Day-to-day support of the quality document control workflow, which is the vehicle to execute the request for changes within a ISO 9001 and Pharmaceutical GMP Quality Management System.

Support the coordination, preparation, and implementation of controlled documents via Document Change Orders (DCOs) and Engineering Change Requests (ECRs).

Assist with global document review boards ensuring that document changes which impact multiple sites are appropriately updated congruently to prevent process drift.

Create, manage, and perform training session in person and during the zoom meeting.

Work with IT and QA Team members to develop better monitoring analysis tools/reports

Compile master data for entry into Agile document management system

SenDx Medical/Radiometer – San Diego, CA Jan 2021 – Feb 2021

Document Control Specialist (Contractor) – Medical Devices

Collaborate with a team of eight to complete an audit of 30,000 customer complaints for blood gas analyzer sensors and consumables

Review hundreds of the product manufacturing documents for SOP errors/issues

Organize customer complaints & manufacturing errors into excel for deeper analysis and process improvements to send to leadership

Thermo Fisher Scientific – San Diego, CA March 2019 – June 2020

Digital Marketing Specialist – Global Merchandising (Contractor)

Managed web merchandising initiatives and processes for new medical device marketing campaigns

Implemented web-only pricing promotions for retail products across the globe

Performed segmentation analysis and evaluation of our web visitors for use in marketing automation campaigns

Performed A/B testing for web banners and marketing pages

Managed, approved, uploaded web content into AEM & CQ and rollout onto thermofisher.com

Partnered with merchandising managers across the businesses and regions to support campaigns and identify opportunities to drive incremental revenue

Analyzed KPIs and advises marketing teams of opportunities to optimize campaign performance

Trained business partners on merchandising capabilities and processes

Worked with marketing teams to gather requirements, translate business needs into technical execution for web merchandising functionality.

Help and administer the cGMP training program and other Quality documents and training courses to maintain adherence to quality

Reported on merchandising performance and highlights insights to drive decision-making & initiative prioritization.

Analyzed performance of banners ads and web content through PowerBI, 4ST, and Adobe Analytics

Good Source Solutions Sept 2017 – March 2019

Inventory Coordinator

Prepared weekly inventory reports to accurately forecast item quantities and to inform sales staff

Analyze and forecast inventory of over 1,300+ products

Completed month end reports for warehouse inventory and accounting for all shipped sales orders

Review, adjust, and invoice sales orders, so customers were charged correctly and promptly

Worked with the sales staff to help complete their sales orders – 300 to 400 orders per month

Communicated with warehouses, shippers, and customers to make sure orders accurately delivered

Starfire Direct Oct 2016 – June 2017

Web Content Assistant

Created a social media marketing plan and implemented it weekly on Facebook, Twitter, Instagram, & Pinterest

Contacted vendors and their brands to gather information to create product webpages in Magento using HTML

Collaborated with Catalog Team to update company website with new products – added 1,300+ products

Executed email campaigns to 20,000 Starfire Direct subscribers

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