Olymp Nola

Olymp Nola 2608 SW 139TH ST, OKC, OK 73170 | E-mail:--Phone: - | Holds a Department of Defense Secret Level Security Clearance Multiple years in various leadership positions with operational expertise in compliance, safety measures, and logistics. Proven ability to enhance team performance and morale through effective training and strategic planning. Able to facilitate military experience in any role to foster continuous growth and excellence Employment Experience Oklahoma Military Department; Joint Force HQ | 3501 NE Military Cir, Oklahoma City, OK 73111 Supervisor: Harvetta Renee Taylor Hours per Week: 40+ | GS-1102-09 Contract Specialist 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. Assisted in acquisitions planning in supply and/or services contracts where specifications are standardized within a competitive market where price competition exists. Provides guidance to the requiring activity 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 variety of contracts that require special handling provisions or specialized terms and conditions for the duration of the acquisition life cycle. Develops solicitations, procurement plans using previous history files, market conditions and technical data to build the appropriate package in order to make award recommendations and/or evaluate responses. 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 includes 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. Provides guidance, advice, and assistance to technical or customers, contractors, and program personnel where information is needed. Pharmacy Management Consultants | 1132 NE 13th St, Oklahoma City, OK 73117 Supervisor: Devin Wilcox Hours Per Week: 40+ | GS-09 pay equivalent and responsibilities Program Manager 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 Ensures the evaluation of programs and instructions by developing unit divisional goals and objectives 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 Janssen Pharmaceuticals | 800 Ridgeview Dr, Horsham, PA 19044 Supervisor: Michele Laudenslager Hours Per Week: 40+ | GS-13 pay equivalent and responsibilities Senior QA Specialist       Maintain oversight of the manufacturing facility for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly Escalate quality issues through management in order 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. Enter data into eLIMS Alert Supervision of any nonconforming results, out of trend, or out of specification results Support supply chain logistics for on time shipment from CMO to Warehouse Qualgen, LLC. | 301 Enterprise Drive, Edmond, Oklahoma 73012 Supervisor: Amy Engels Hours Per Week: 50+ | GS-9 Pay equivalent and responsibilities Quality Assurance Associate             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. 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. Generate change requests required for GMP documents and routes documents for review and approval. Maintain hard copies and electronic files of technical documents. Support overall FDA/GMP compliance initiatives and internal/external audits. Additional adapting essential regulatory guidance to re-mediate concurrent observations of technical criticality. Cytovance Biologics | 800 Research Pkwy, Oklahoma City, OK 73104 Supervisor: Tiffany Moeder Hours Per Week: 40+ | GS-9 Pay equivalent and responsibilities Quality Assurance Operations Associate  10/2021 - 08/2022 12/2018 – 08/2019 Initiate and revise Standard Operating Procedures (SOP) to improve compliance with laboratory functions. Audited classified areas which included: processing, clean room releases, documentation review and retention, and acceptance sampling. Examine science lab conditions to ensure it conforms to OSHA Standards and safety regulations. Review records to ensure they are complete, accurate and compliant with Good Manufacturing Practice (GMP) as it pertains to 21 CRF part 210 and Good Documentation (GDP) requirements. Batch records and logbooks are assessed for completeness, accuracy, and compliance with current cGMP requirements along with other documents in the manufacture of drug product(s). Additionally reviewed stability packets and quality control testing results for completion and accuracy as it complies with the SOP, and for any deficiencies to be identified.      Maintained gowning qualifications for clean room classification standards equivalent to ISO 5, 7, and 8. Perform and analyze event trending to identify areas for improvement along with review of root cause assessments and impact analysis, and reporting errors, deficiencies, discrepancies and other various observations to management. Used established technical writing skills to write reports and documentation of necessary data received from any manufacturing, validation, and regulatory records for metrics trending. Interface with client Quality Assurance as directed by supervisor, providing notification of events impacting client product and materials not limited to assigning risk rating to quality systems and performing risk assessments to improve workplace guidelines. Support the CAPA System and Quality System requirements, to include initiating, authoring, reviewing, and approving Investigation Reports (IR/EI), Temporary Change Requests (TC), Nonconforming Material Reports (RLN), and Corrective Actions (CA) for assessment and resolution of events. Stephenson Cancer Center | 800 NW 10th St, OKC, OK, 73104 Supervisor: Rindi Ledo Hours Per Week: 40 | GS-5 Pay equivalent and responsibilities Clinical Trials Oncology Auditor        06/2015 – 12/2018 Audited site-specific and affiliate clinical trials in compliance with federal, sponsor, and internal guidelines. Performed various types of audits for cooperative sponsor groups, investigator initiated trials, and minimal pharmaceutical and Phase I Studies. Monitored study procedures, good clinical best practices, and patient documents to identify noncompliance. Advised supervisor of any protocol deficiencies and maintained all records of such. Prepared staff for NCI and FDA audits by performing routine and systematic internal audits in preparation of an external audit provided that audit reports containing useful recommendations for reducing the lack of compliance and deficiencies of a research trial. Compiled data and prepared specific reports of audit findings based on knowledge of Good Clinical Practice, policies, regulatory guidelines, and federal regulations by conventional methods. Coordinated activities of fellow associates and trial investigators to ensure compliance with research protocols and clinical objectives. Maintain reports and documentation of protocol research audits including informed consent documents, deficiency/deviation reports, case report forms and the management of the data online, protocols, and assisting with drafting updates on source documentation. Executes review of research material following an internal or external audit with the aim to improve the efficacy of trial conduct, demonstrating organizational excellence, strong decisionmaking, and management of multiple projects in a fast-paced environment. Educational Background Defense Acquisitions University Contract Specialist certification (multiple educational courses*)  CON 1100V – Contract Foundational Skills  CON 1200V – Contract Pre-award  CON 1300V – Contract Award  CON 1400V – Contract Post-award University of Oklahoma Bachelor of Science-Multidisciplinary Studies - Health & Medicine  Minors in Health & Exercise Sciences and Psychology Completed Completed Completed Completed 08/2007 – 05/2015 Oklahoma City Community College Associates-Clinical Research Coordinator Clinical Research Coordinator Accredited Program  Certificate of Mastery in Clinical Research Coordinating Oklahoma City Community College Associates- Biology - Allied Health 08/2016 – 05/2017 08/2009 – 12/2011 Military Educational Background Advanced Field Artillery Tactical Data System (AFATDS) Refresher Course 02/03/25 – 02/07/25 Basic Officer Leadership Course – Field Artillery 08/2023 – 01/2024 Officer Candidate School 3-11 INF BDE 2nd Lieutenant; Commissioned 02/23/23; Branch Field Artillery 11/2022 – 02/2023 Military Service & Experience United States Army (National Guard) Promoted 1st Lieutenant 08/23/2024 08/2022 – Present Fire Directions Officer 10/2024 – Present  Oversaw multiple gun sections operating the M777A3 Howitzer, maintaining high standards of accuracy and efficiency through progressive training and certification processes for operational readiness.  Managed Fire Direction Center operations, ensuring fire mission directives are carried out with precision of artillery support during missions.  Managed and assisted with the development of training regimens across the battery, fostering a culture of standards, readiness, and excellence.  Trained FDC personnel on operational procedures, table certifications, and internal development to improve data accuracy and fire order effectiveness.  Assisted with multiple field training events, vehicle maintenance, and equipment readiness to enhance overall unit performance.  Acted as officer in charge for military training operations that include range operations, weapons qualifications, physical training readiness, etc.  Constructs safety measures prior, during, and after conduct of military training events in conjunction with range safety operators to avoid mishaps, personnel injuries, and surrounding environment hazards. Fire Support Officer 01/2024 - 09/2024  Oversaw maintenance and readiness of vehicle, weaponry, communication systems, and personnel; managing and assumed accountability for millions of dollars wroth of equipment.  Provided cross training to forward observers on table certifications for operational readiness: planning, directing, and managing the employment of observer platforms.  Led unit at the platoon level in artillery combat operations training to ensure effective fire support for ground troops.  Bolstered unit morale and welfare through effective leadership and support for unit personnel  Integrating the fire support plan with the company operation order and addressing fire support tasks during rehearsals, basing actions on the supported needs of the unit as directed by the maneuver commander’s guidance.  Assisted with troubleshooting through deficiencies while employing fire support measures, using vehicles and/or precision targeting equipment to maximize their capabilities. Skills  Able to assess quality systems utilizing best practice methods and process evaluation by critical and analytical thinking to address process changes to assist in strategic process development and improvement.  Leading, coordinating, beginning, and completing complex audits and various projects efficiently  Able to analyze research data, data governance and maintenance, accurate entries, and able to identify issues released to regulatory and operational deficiencies for process, system, and operational improvements.  Proficient in specific organizational software, and Microsoft Office tools such as Word, Excel for data tracking, and Powerpoint for providing training and presentations  Ability to utilize resources and analytical reasoning through various and multiple regulatory agencies for compliance that include, but are not limited to: United States Pharmacopoeia, FDA Good Clinical/Manufacturing Practices  Able to provide training and presentations relevant standards and procedures in within planned conferences and various panels.  Firm understanding of logistics coordination and able to employ measures to oversee equipment valued upwards of millions of dollars. Affiliation and Charity Officer Candidate School Student Council Secretary -Armed Services Blood Donation Drive Jan 2023 – Feb 2023 Society of Clinical Research (SoCRA) - Member June 2015- Dec 2018 Stephenson Outpace Cancer Race 5K- Volunteer Summer 2018 Gamma Beta National Fraternity, Inc. - Chapter Founder -Hepatitis B Foundation Fall 2008 Alpha Phi Omega Fraternity - Member Fall 2008 OKLAHOMA REGIONAL FOOD BANK – Volunteer 2006 – Present Professional References Michele Laudenslager Title: Quality Assurance Director Location: Johnson & Johnson / Janssen Pharmaceuticals Pennsylvania Phone number: - E-mail Address:- Joseph Laws Title: 1-160th FA / Charlie Battery Commander Location: Fort Sill, OK Phone number:- E-mail Address:- Ali Radmard Title: Data Operations Team Lead Location: Stephenson Cancer Center Phone number:- E-mail Address:- Abraham Liongco Title: Mechanical Engineer Location: Tinker Air Force Base Phone number:- E-mail Address:-