Jennifer Blinn

Manager with over 25 years of experience with Quality Management Systems in the Life Science Industry. Experience with clinical trials, pharmacovigilance, validation, audits and inspection readiness.

Internal Auditor, Goodpoint - Semcon - Stockholm, Sweden

(2023-09 - 2025-07)

• Internal inspection of Goodpoint's Quality System and processes in preparation of external audit for renewed ISO9001/14001 certification

Inspection Coordinator, Astra Zeneca - Semcon - Stockholm, Sweden

(2023-09 - 2025-07)

• Coordinate process team in response to inquires during regulatory inspections (e.g. Livsmedelverket, customer countries)

Validation Manager, Astra Zeneca - Semcon - Stockholm, Sweden

(2023-09 - 2025-07)

• Design and test planning for installation of new Distribution Control System (DCS) at API factory
• Testing and planning of configurations to process control system (PCS) to accommodate conversion of manufacturing line (preparation, BFS filling and packaging) from production of Bricanyl respules to Pulmicort respules

QA resource - Novavax - Epista Life Science - Stockholm, Sweden

(2021-11 - 2023-09)

• QA resource to supply chain resources (e.g. warehouse, planning, QA product release, etc.) during SAP implementation

Compliance Specialist - Cerba Research - Epista Life Science - Stockholm, Sweden

(2021-11 - 2023-09)

• Performed Compliance Gap Assessment of a Clinical Trial Management System

Quality and Testing advisor - FinVector - Epista Life Science - Stockholm, Sweden

(2021-11 - 2023-09)

• Quality and Testing advisor for the Quality Management (e.g. data integrity, change control, firewall upgrades) of digital systems including Dynamic AX ERP system

Testing - Sobi - Epista Life Science - Stockholm, Sweden

(2021-11 - 2023-09)

• Testing of Veeva Training and Quality Docs modules

Validation Engineer - Octapharma - AFRY/ÅF Industry, Food and Pharma - Solna, Sweden

(2015-04 - 2021-11)

• Installation and cleaning validation of a new facility for the manufacturing of blood products (Clean room class B); qualification of automated calibration equipment

Validation Engineer - Johnson & Johnson - AFRY/ÅF Industry, Food and Pharma - Solna, Sweden

(2015-04 - 2021-11)

• Design and installation qualification of new thermocompressors to Water for Injection (WFI) system

Validation Engineer - GE Healthcare - AFRY/ÅF Industry, Food and Pharma - Solna, Sweden

(2015-04 - 2021-11)

• Qualification of a new lab and membrane manufacturing facility in Stevenage, England to include WFI, LAF units, etc.; SAT testing of media and hydraulic systems to a rotating hutch installed in Uppsala

Validation Engineer - Astra Zeneca - AFRY/ÅF Industry, Food and Pharma - Solna, Sweden

(2015-04 - 2021-11)

• Qualification of the reconstruction of WFI system to Turbohalerproduct and construction of a new biologics facility (including FAT of a class A isolated syringe filler)

Quality Assurance Engineer - PRC Engineering - Stockholm, Sweden

(2007-03 - 2015-04)

Focus here was often quality assurance of commissioning activities (design and implementation) of the automated systems which steer the production, batch reporting and cleaning systems in the GMP environment.

• Octapharma – qualification of newly installed equipment and changes to media systems (e.g. WFI, UF SCID, autoclave)
• Astra Zeneca - documented testing of the virtualization of production systems
• SOBI Biovitrum – quality control of design and testing of a Siemens PCS7 batch control, WFI and Clean-In-Place (CIP) control system to ensure compliance with regulatory requirements and client specifications
• McNeil - quality control of design and testing of a Siemens PCS7 recipe and batch control system including preparation, coating and cleaning functions and the preparation of electronic batch reports to comply with GMP and 21 CFR part 11 requirements

Drug Safety Specialist - Astra Zeneca - Södertälje, Sweden

(2006-02 - 2007-02)

Responsible for monitoring safety profiles of anesthetic products marketed globally. Collaborated with the drug safety and regulatory affairs teams in the coordination and submission of Periodic Safety Reports (PSUR) for global renewal in accordance with international regulations. Participated in qualification testing of an adverse event tracking database.

Associate Manager, Quality Systems - Schering-Plough, Worldwide Research QA - Lafayette, NJ, USA

(2003-01 - 2005-09)

Performed internal audits and advised working units on compliance with FDA regulations and internal SOPs. Performed GXP education.

Validation Engineer - The Validation Company - Thousand Oaks, CA, USA

(2003-01 - 2003-12)

Performed validation testing on a back-up and archive system for laboratory equipment. Assignment was based at Baxter Bioscience in California yet required collaboration with several sites throughout the USA

Validation Engineer - The European Division of CSSC, Inc. - Morristown, NJ, USA

(2001-01 - 2003-12)

Performed validation testing of new equipment. Validated a labeler on a packaging line for a client in NJ. Spent 6 months on-site in Paris (Galderma) validating an adverse event tracking database to ensure compliance with user and regulatory requirements, including FDA 21CFR part 11 compliance.

Clinical Research Associate - Clingenix/RSI and Quintiles - San Diego, CA, USA

(1998-01 - 2000-12)

Represented sponsor companies in the management of clinical trials. Prepared medical staff at hospitals, clinics and general practitioner's offices throughout the USA for participation in clinical trials. Educated staff on applicable FDA regulations, computerized systems and protocol requirements.

Performed regular site visits to ensure compliance with GCP and GDP during participation of sponsor led clinical trials. Reviewed medical charts for adequate reporting of adverse events and clinical trial documentation for adequate documentation of study participation (e.g. patient consent, protocol requirements).

Clinical Trial Coordinator - Strong Memorial Hospital - Rochester, NY, USA

(1992-01 - 1998-12)

Managed clinical trials in a clinical environment. Enrolled and monitored the progress of patients in oncology clinical trials. Collaborated with the medical team to ensure adequate documentation of adverse events (manually and electronically). Served as liaison between clinical trial sponsor and medical staff which included educating on regulatory requirements, protocol requirements and updates, etc.

Master of Science - Natural Resource Management, Governance and Globalization - Stockholm University

Bachelor of Art - Psychology - University of Rochester