Quality Assurance Compliance Analyst

Conϐidential

RIC LOMIBAO

Seattle, WA 206-***-**** *******@*******.*** https://www.linkedin.com/in/riclomibao/ PARALEGAL AND QUALITY ASSURANCE OPERATIONS

Seasoned Paralegal and Compliance Analyst with 15+ years or experience. Looking for an opportunity to utilize my demonstrated value in providing extensive legal, documentation and regulatory (biopharma) knowledge, organizational skills and collaborative competency working across diverse industries

PROFESSIONAL ACCOMPLISHENTS

• Conducted legal document research, managed ϐile organization, streamlining legal and governmental documents to decrease labor time.

• Sole support of issuance and distribution of records supporting Good Manufacturing Process (GMP) operations in a multiproduct manufacturing facility making sure to meet critical deadlines.

• Reviewed, veriϐied, and distributed client stability and contract testing records. For example, my company achieved a $2 million dollar milestone because I uploaded a DHR (Drug History Records) by a critical deadline in support of an FDA regulatory audit.

• Scanned, reviewed, formatted, veriϐied, and uploaded GMP manufacturing documentation.

• Developed and implemented internal policies and procedures related to marketing and advertising compliance for each cDMO product adhering to FDA, FCC and FTC regulations.

• Provided training and created reference/work instruction binders to the marketing team on legal requirements and best business practices for advertising finished/final products in the USA and European Union (EU). PROFESSIONAL WORK EXPERIENCE:

Paralegal II /Quality Associate II 04/2018 – 05/2024 AGC Biologics ( www.agcbio.com )

In Plant Quality Assurance Associate II

• Insured all manufacturing suites had functional communication channels to enhance safety in the GMP facilities.

• Worked with manufacturing/management to troubleshoot any issues and ensure production stays within GMP compliance. including on-call support to provide guidance for 24/7 Manufacturing operations. Trained associates on In Process Quality Assurance (IPQA) activities.

• Served as an initial contact point between Manufacturing, Quality, Quality Control, Engineering, Supply Chain, Project Management and MSAT when issues occurred during current manufacturing processes.

• Reviewed in-plant GMP production records for accuracy, completion, and compliance with speciϐications. Initiated, supported and assisted in deviation investigations, CAPAs, CRRs requests to deϐine objectives, root causes, deliverables, ownerships, due dates, effectiveness requirements and closure of each request. Facilitate requesting various team members to support deviations and CAPAs. Transition CAPA to the owning department SME and ensure CAPA and deviation closure in a timely manner.

• Performed Product Change Over (PCO) review and release of manufacturing suites and equipment to support manufacturing operations. Supported GMP compliance for FDA/EMA regulation audits.

• Core Member of the Emergency Response Team, Safety and Wellness Committee representing the US site operations.

• Reviewed and veriϐied Material Request (MR) forms for the Warehouse, Emergency MR’s daily and as needed.

• Drafted and reviewed over 150 legal documents monthly, ensuring compliance with all state and federal regulations, which contributed to an enhanced approval rate of 95%.

• Streamlined document review processes, increasing efϐiciency by 25% through the implementation of electronic case management systems and meticulous compliance with legal standards and protocols. Document Control II

• Primary Point of Contact for Emergency Documentation Requests from Manufacturing to support 24/7 GMP operations including Corporate Regulatory Audits, including FDA, DEA, and GDPR.

• Process, release, and maintain controlled documents; distribution of ϐiles to satellite locations to maintain library integrity.

• Issuance of Master Batch Records (MBRs) and applicable sampling labels. Review and process requests for replacement MBRs. Create and distribute DHRs for all GMP products manufactured in compliance with data integrity and legal retention requirements.

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• Organize and maintain Archive Room; Catalog and Archive ϐiles to GMP off-site secured location, processed document retrievals.

Safety Committee Chairman

• Served as the main onsite employee Safety Committee Chair serving the EHS department for a mid-sized FDA-regulated biologics contract development and manufacturing organization (CDMO) for 7 buildings including three large clean rooms

(ISO 8/Grade C), a chemical warehouse, and several biological and chemical labs.

• Grew the Emergency [hazardous material spill] Response Team by 30% by recruiting several new members, arranging training, and outϐitting with equipment, which resulted in gaining night and weekend shift coverage.

• Maintained environmental compliance by leading the ISO 14001 environmental management systems audit with our registrar, which has zero minor or major ϐindings.

• Managed and administrated multiple PPE programs, i.e., Steel-Toe Safety Shoe Voucher Program, which issued vouchers for over 100 shoes, and prevented debilitating foot crush injuries. Corporate Paralegal/Legal Support 01/2018 – 03/2018 Garden City Group (GCG) (Deepwater Horizon Oil Spill 2010)

• Reviewed individual claim ϐile documents to determine eligibility to claim ϐiling(s). Categorize documents for ϐinal claim review and ϐinancial pay-out(s) from the various class action cases.

• Reviewed the claims to conϐirm appropriate documents in support to each claim ϐiled. Communicated with claimants and attorneys regarding completeness of claim ϐilings and documentation.

• Assisted in drafting and reviewing corporate contracts, shareholder agreements, and compliance documents, leading to a 30% decrease in legal processing time using legal research databases like LexisNexis and Westlaw. Corporate Paralegal/Legal Support 09/2017 – 12/2017 TerraPower LLC (Global Pharmaceutical Nuclear Fusion Project)

• Performed due diligence review and marking and updated conϐidential and proprietary documents for a global JointVenture Capital project. Lead Paralegal on 'project' and coordinated assignments within the Team. Audited the team's weekly progress to meet company metrics in a timely manner.

• Implemented quality initiatives in document review processes, reducing errors by 20% and ensuring compliance with regulatory standards using advanced legal software over a 12-month period.

• Drafted and reviewed over 150 legal documents annually, including contracts, pleadings, and corporate governance documents, ensuring compliance with regulatory standards, and reducing errors by 25%. Corporate Paralegal/Legal Support 01/2017 – 08/2017 Amazon Corporate LLC

• Managed and prioritized complex calendars of VPs on conϐidential projects based on business needs and objectives. Partnered with Executives to strategize in the most effective and efϐicient ‘Amazon’ way on long term projects. Supported AWS Global Marketing Sales division with day-to-day business transactions with Amazon and its’ subsidiaries.

• Performed legal review of contract requests to Vendor/Client’s for ϐinal review and approval via DocuSign achieved a near 100% daily completion rate meeting all internal metrics. Interacted with other Internal AWS CSR on Signatory Status, such as Non-Disclosure Agreements (NDA), Mutual Non-Disclosure Agreements (MNDA), Enterprise Agreements and Afϐiliated Addendum, Enterprise Agreement Amendments, Reseller Agreements, Data Processing Addendums, Master Service Agreements (MSA), Work Orders to MSA, “Value-Added Reseller Agreements” (“VARA”), AWS General Data Protections Regulations (“GDPR”), Data Processing Addendums (“DPA”).

• Uploaded and ϐiled fully executed contractual agreements within Amazon’s SharePoint databases, i.e., ‘iManage” for ϐinal safe keeping depository in a structured ϐiling naming convention.

• Managed a portfolio of 200+ legal contracts, ensuring compliance with regulatory requirements and reducing contract processing time by 30% through the implementation of an automated document management system. Paralegal II /Quality Systems Analyst I 02/2016 – 12/2016 CMC Biologics

• Provided support for FDA and other regulatory authorities and 'On Call after hours support' to produce biopharmaceutical materials for human consumption. Participated in the FDA direct supplier interactions including but not limited to, obtaining/review supplier certiϐication documentation, reviewing assessing 'Supplier Change Notiϐications' and following up on supplier investigations.

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• Reviewed, updated, and scanned executed FDA and other government documents into a secured computerized system

(Master Control TM) along with other related documents into SharePoint, i.e., FDA GMP documentation (training ϐiles, archive room, volume of documents).

• Supported Corporate Regulatory Agencies Audits, including FDA, DEA system improvement protocol action items related to protocols, and legal review of disposition documents prior to archiving, with a 98% completion rate. Cataloged and Organized Archived ϐiles to GMP off-site secured location, processed document retrievals.

• Spearheaded the facilitation of over 50 legal document reviews and quality system audits per quarter, leveraging tools such as MS Word and SharePoint to achieve a 95% accuracy rate while ensuring compliance with regulatory requirements and internal standards.

Also worked as a Corporate Paralegal for Amazon, Starbucks, Init and T-Mobile USA. EDUCATION

University of California at San Diego, La Jolla, CA (BS degree, In-Process) General Biology; Computer Science Boston University, Boston, MA Paralegal Certiϐicate

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