Tobacco Compliance Data Specialist – FDA (Food & Drug Administration)
San Marcos, Texas, United States
$3k-$4k/moOnsiteFull Time
Texas State University: Public research university offering undergraduate and graduate degree programs.
U.S. citizenship, administrative experience, Microsoft Excel proficiency, data validation, compliance evaluation, and accurate data maintenance across multiple platforms. Bachelor's degree preferred.
Houston or Dallas or Austin or San Antonio or Texas or Missouri or Kansas or Arkansas or Oklahoma
FieldFull Time
Krystal BiotechNASDAQ: KRYS: Develops and sells redosable gene therapies for rare diseases.
5+ YOEBachelor's degree, 5+ years in patient services, field reimbursement, biopharma sales, or account management, including 1+ year supporting patients; rare disease, HIPAA, and FDA knowledge required.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
2+ YOEBachelor's degree or equivalent qualification and 2+ years of relevant experience. Requires clinical study operations knowledge, FDA regulations, ICH GCP, Microsoft Office, communication, organization, and project budgeting skills.
Bakerly: Produces and sells authentic French-style brioche and crêpes.
4+ YOERequires 4+ years in inventory control, warehouse operations, materials management, or supply chain; ERP/WMS and Microsoft Excel proficiency; forklift experience; knowledge of FIFO, FEFO, traceability, GMP, SQF, and FDA compliance.
ERP, Warehouse Management Systems (WMS), Microsoft Excel, FIFO, FEFO, GMP, SQF, FDA
DiaSorinBorsa Italiana: DIA: Develops and manufactures in vitro diagnostic tests and laboratory equipment.
1+ YOEReview DHRs for FDA (21 CFR 820) and ISO 13485 compliance; H.S. diploma required (Associate's preferred); 1+ year in FDA-regulated manufacturing; audit and quality certification preferred; Microsoft Windows/Office and Oracle familiarity.
Pinnacle Clinical Research: Provides multi-site clinical trial and medical research services.
1+ YOEPhysician with clinical practice in Internal Medicine or Family Practice; knowledge of FDA regulations and GCP; bilingual English/Spanish preferred.
TakedaTokyo Stock Exchange / New York Stock Exchange: 4502 / TAK: Researches, develops, and manufactures prescription pharmaceutical medicines.
2+ YOEEMT-Paramedic licensure required, CPR/AED and basic IV therapy, FDA BioLife medical support training, and two years clinical or hospital experience.
FlexNASDAQ: FLEX: Contract electronics manufacturing and supply chain management services.
3+ YOEBachelor's degree in related field, 3 years experience, Allen Bradley RS Logix or Siemens PLC programming experience; FDA regulated manufacturing preferred.
Urology San Antonio: Provides specialized medical and surgical care for urological conditions.
Prepare and submit IRB and regulatory documents, maintain regulatory binders, ensure compliance with FDA/ICH/GCP/HIPAA/IRB requirements, and respond to sponsor/IRB queries.
Tekton Research: Clinical research site network conducting Phase 1-4 medical trials.
1+ YOEMinimum 1 year CRC experience, knowledge of GCP/FDA/ICH, phlebotomy and specimen processing, EDC and Microsoft Office proficiency, strong organization and communication skills.
Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Microsoft Office
Extremity Care: Developer of regenerative tissue grafts and medical billing solutions.
1+ YOEHigh school diploma or equivalent and 1+ year hands-on aseptic technique experience required; related associate's or bachelor's degree may substitute. FDA-regulated experience preferred.
Microsoft Office, FDA 21 CFR 1271, FDA 21 CFR 820, ISO Standards
Pinnacle Clinical Research: Clinical research site network conducting complex therapeutic trials.
1+ YOEManage day-to-day clinical trial operations, recruit and engage participants, complete study assessments and documentation, comply with GCP/HIPAA/FDA regulations, and communicate with sponsors and vendors.
Whataburger: Operates a regional fast-food chain specializing in large hamburgers.
5+ YOEBachelor in Food Science or related field; 5+ years in FSQA; HACCP, GMPs, FDA Retail Food Code; supplier QA programs; strong communication; MS Office.
OriGen Biomedical: Manufactures medical devices for cryopreservation and cell culture.
4+ YOEBachelor's degree in engineering or 4+ years engineering experience in medical devices/ISO 13485, knowledge of FDA/GMP, DOE/validation, strong problem solving and communication skills.
Siemens HealthineersFrankfurt Stock Exchange: SHL: Provides medical imaging and diagnostic solutions to healthcare providers.
3+ YOEMaster's in mechanical/industrial engineering or related plus 3 years' relevant experience; experience with CAD, prototyping, validations, GMP/FDA compliance, process optimization, and project management.
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
0.5+ YOEHigh school diploma or equivalent; external candidates need 6 months of phlebotomy experience, with medical or healthcare experience preferred. Must follow SOP, FDA, HSE, and OSHA requirements.
Personal Digital Assistant (PDA), electronic donor information management system
Toledo or Midland or Columbus or Lima or St. Paul or Portage or Austin or Huntsville
$150k-$160k/yrOnsiteFull Time
SSOE Group: Provides architecture, engineering, and construction management for industrial facilities.
10+ YOEBachelor's in Mechanical Engineering, PE preferred or in-progress,10+ years engineering experience in pharmaceutical/life sciences facilities, experience with FDA/cGMP environments, project leadership and multidisciplinary collaboration.
The Specialty Alliance: Provides operational and administrative support to specialty medical practices.
Follow study protocols and GCP/FDA/ICH requirements, perform screening, vitals, ECG, specimen collection/processing, use EDC, maintain HIPAA compliance, and communicate with patients and study team.