Summary
Overview
Work History
Education
Skills
Affiliations
Military Experience
References
Websites
Timeline
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Olymp Nola

2608 SW 139th St Oklahoma City,OK

Summary

Experienced in industry sales, service and risk mitigation. Adept at working with customers to sell products and services and enable remarkable account growth. Positive, upbeat, and flexible in providing each customer with optimal solutions which meet individual company requirements.

Overview

5
5
years of professional experience

Work History

Contract Specialist

Oklahoma Military Department Joint Force Headquarters
Oklahoma City, OK
06.2024 - Current
  • Performed development assignments, assisting the contracting officer in the application of common contracting methods and types, and assist in the procurement of standard or specialized service.
  • Contributed to acquisition lifecycles by applying technical evaluation criteria and market research techniques to enhance sourcing strategies, integrating Federal Acquisition Regulations and electronic data management systems throughout procurement processes.
  • Provides guidance to the requiring activity (customers) and contractors alike, using logical reasoning and critical thinking to interpret multiple government regulatory guidance such as the Federal Acquisitions Regulations (FAR), Army Federal Acquisitions Regulation (AFARS), etc.
  • Responsible for managing variety of contract that require special handling provisions or specialized terms and conditions for the duration of the acquisition life cycle.
  • Evaluates prospective contract prices through basic price and cost analysis techniques by research and review of precedent data.
  • Served as the alternate Government Purchase Card Agency Organization Program Coordinator; duties include tracking training for billing/approving officials and cardholders within the program, performing compliance reviews and prepares reports for submission to higher headquarters.
  • Prepares letters, memoranda, documents, or reports that support contractual actions under close supervision.
  • Supported decision-making by researching regulatory standards and sharing actionable advice to clients and customers on contract provisions using technical knowledge of acquisition policies and procedures.
  • Presented contract analysis findings and recommendations to cross-functional teams over a week to week period, leveraging advanced communication skills to foster client needs to align and ensure compliance with FAR/AFARS regulatory standards.

Program Manager

Pharmacy Management Consultants
Oklahoma City, OK
05.2023 - 06.2024
  • Directs program administration, overseeing all budgets and contracts within the Therapy Prior Authorizations program, interpreting and developing policies and procedures, and supervision of all staff within the department.
  • Monitors projects, program evaluation, and both short and long-range plans.
  • Assists with writing contract proposals, followed by managing contracts to the required specifications.
  • Oversaw budgetary and contractual operations while maintaining a centralized computer database of prior authorization cases.
  • Ensures the evaluation of programs and instructions by developing unit divisional goals and objectives are executed on time and within scope by setting clear time frames and performance expectations.
  • Participates in committees and meetings where needed and represents the unit to public and client groups.
  • Oversees project management with the director, performing various duties as needed to successfully fulfill the function of the position, program, and company.
  • Spearheaded change management initiatives over a 24-month period, guiding 3 cross-functional teams through two major system upgrades and adopting new portfolio management tools, resulting in a 27% reduction in project delivery timelines while supporting 200+ prior authorization cases per week.
  • Facilitated team collaboration across 3 professional disciplines using Agile methodologies during a portfolio integration, enabling a 35% increase in on-time deliverables and successful completion of prior authorization case reductions monthly.

Senior Quality Assurance Specialist

Janssen Pharmaceuticals
Horsham, PA
10.2021 - 08.2022
  • Maintain oversight of the manufacturing facility for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly using an enterprise computer database (eLIMS) for accuracy and compliance.
  • Escalate quality issues through management to provide client resolution.
  • Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications.
  • Ensure all required testing and documentation is provided and meets release requirements.
  • Flagged, troubleshot, and escalated any nonconforming results, out of trend, or out of specification results as needed.
  • Support supply chain logistics for on time shipment from CMO to Warehouse.
  • Directed cross-functional quality audits and data reviews over 18-month span to maximize client success, leveraging eLIMS tracking and compliance tools to deliver 99% on-time release and shipment for 120+ commercial drug product batches annually.
  • Streamlined batch release reviews across 120+ annual products by applying adaptability with eLIMS and Veeva Vault QMS over 10 months, decreasing release times by 22% and meeting shifting regulatory targets without delays.

Quality Assurance Associate

Qualgen, LLC.
Edmond, OK
02.2020 - 08.2021
  • Issue technical documents such as: Working Batch Records, Certificates of Analysis, Validation Protocols and Reports, Method Transfer Protocols/Reports, and Standard Operating Procedures according to company standards and FDA/ICH guidelines.
  • Perform Good Manufacturing Practice (GMP) batch records, validation protocol and general document review.
  • Interpret proper process controls in regards to manufacturing sciences; evaluating at minimum, various quality control results to sterility testing and other microbial parameters.
  • Organize, illicit control and provide oversight of all scientific processes and Standard Operating Procedures in accordance with: Good Manufacturing Practices 21 CFR part 211, the Food and Drug Administration 503B Outsourcing Facilities, and the United States Pharmacopeia.
  • Generate change requests required for GMP documents and routes documents for review and approval.
  • Maintain GMP document control and ensure that the integrity and accuracy of all GMP documents are maintained in regards to 21 Code of Federal Regulations part 210.
  • Support overall FDA/GMP compliance initiatives and internal/external audits including maintaining hard copies and electronic files of technical documents.
  • Implemented software knowledge in TrackWise to streamline GMP document management workflows over a 12-month period, facilitating 100+ audit-ready records monthly while ensuring 100% adherence to FDA data integrity standards.
  • Applied analytical skills to evaluate 50+ batch deviations per quarter using TrackWise, performing root cause investigations and data trend analysis to enhance GMP compliance and reduce document errors by 15% over 12 months.
  • Directed cross-functional investigations for 40+ quality issues per quarter utilizing Microsoft professional software, harnessing advanced problem-solving approaches to resolve non-conformances and meet FDA 21 CFR part 211 compliance targets within strict timelines.

Education

Certification of Mastery - Clinical Research Professional

Oklahoma City Community College
Oklahoma City, OK
01.2017

Bachelor of Science - Multidisciplinary Studies in Health & Medicine, Psychology, Health & Exercise Sciences

University of Oklahoma
Norman, OK
01.2015

Associate of Science - Biology (Allied Health)

Oklahoma City Community College
Oklahoma City, OK
01.2011

Skills

  • Management expertise
  • Documentation review
  • Contract performance management
  • Acquisitions
  • Market integrity
  • Risk mitigation
  • Quality assurance
  • Team oversight
  • Risk management and monitoring
  • Document control
  • Contract administration
  • Contracting policies and regulations
  • Research and analysis
  • Regulatory compliance
  • Pricing analysis
  • Contract proposals
  • Conflict mediation
  • Contract compliance
  • Contract closeouts
  • Superior client relations
  • Attention to detail
  • Effective communication
  • Critical thinking
  • Decision making
  • Fact-finding and investigations
  • Project management
  • Change management
  • Market research

Affiliations

  • Oklahoma Regional Food Bank
  • Habitats for Humanities
  • True North Ministries
  • Heart & Home Makeover

Military Experience

  • Current 1st Lieutenant Battery Fire Directions Officer
  • Served as a Company Fire Support Officer
  • Officer Candidate School at Fort Benning; held role as Student Council Secretary

References

  • Michele Laudenslager, Quality Assurance Director, Johnson & Johnson / Janssen Pharmaceuticals, mlaudens@its.jnj.com, (610) 207-0860
  • Joseph Laws, Charlie Battery Commander, 1-160th FA / Charlie Battery, joseph.a.laws@gmail.com, 845-489-6601
  • Ali Radmard, Data Operations Team Lead, Stephenson Cancer Center, alireza-radmard@ouhsc.edu, 405-627-7753
  • Abraham Liongco, Mechanical Engineer, Tinker Air Force Base, abraham.liongco@us.af.mil, 405-887-0469

Timeline

Contract Specialist

Oklahoma Military Department Joint Force Headquarters
06.2024 - Current

Program Manager

Pharmacy Management Consultants
05.2023 - 06.2024

Senior Quality Assurance Specialist

Janssen Pharmaceuticals
10.2021 - 08.2022

Quality Assurance Associate

Qualgen, LLC.
02.2020 - 08.2021

Certification of Mastery - Clinical Research Professional

Oklahoma City Community College

Bachelor of Science - Multidisciplinary Studies in Health & Medicine, Psychology, Health & Exercise Sciences

University of Oklahoma

Associate of Science - Biology (Allied Health)

Oklahoma City Community College