jennifer bruce

Vendor Qualification (cGMP audits of raw material vendors, API and drug product manufacturing facilities, testing facilities, labeling & packaging facilities, and holding & distribution facilities in India)

Quality Management of one commercial combination product - Ventavis® ((iloprost) Inhalation Solution (sterile) for inhalation via either of two pulmonary drug delivery devices: the I-neb® AAD® (Adaptive Aerosol Delivery) System or the Prodose® AAD® System) Member of inspection team that hosted one successful FDA audit - Drug Safety, Product Complaints, and Training (No 483's reported) CMC author/reviewer for NDA, sNDA, IND's, and Annual Reports Responsible for all aspects of Quality Assurance including: CMO GMP manufacturing compliance, deviations, CAPA, Change Control, production batch record review and lot disposition Provided on-site CMO production training in Good Documentation Practices (Berlimed, Madrid, Spain) Implementation of the following Quality Systems: Hybrid Document Control system (EDMS - MasterControl), Supplier/Vendor Qualification (cGMP audits), Quality Agreements, CAPA system, Quality Investigations, OOS, Product Complaints, GxP and regualtory training, Clinical supplies packaging/labeling batch record review and approval

* Responsible for all aspects of QA & QC for Phase 1 & 2 drug products (Monoclonal Antibodies) * CMO GMP manufacturing compliance including deviations, CAPA, Change Control, production batch record review and lot release * Implementation of the following Quality Systems: Paper-based Document Control System, Supplier/Vendor Qualifiaction (cGMP audits), Quality Agreements, CAPA, Quality Investigations, OOS, Product Complaints, GxP and regulatory training, Regulatory History File * QA support of Clinical Operations for global trials

* Creation and implementation of a GxP Corporate Training Program including departmental and functional area needs assessments and creation of custom training modules. * GMP, GLP, & GCP Training (Instructional Design & Delivery) * Maintenance of all personnel training records and corresponding qualification documentation * Creation and revision of Quality Systems SOPs, policies, and ISO Quality Manual * Performed routine Internal Quality Audits with the QA audit team * Participated in audits by DHHS, NIAID, State of California, and client due diligence inspections * Successfully defended Corporate GxP Training Program for State of California inspection with no observations

* GMP recombinant collegen and gelatin production for cosmetic, dental, and surgical applications * Document Control Manager (Hybrid - MasterControl and paper-based system) * Performed routine internal audits and CMO audits under the supervision of the Quality Director * Review and approval of production batch records and QC testing data * Provided corporate-wide training for EDMS, GMP Basics, and SOP Writing * Laboratory Notebook review, storage, and microfilming * GMP equipment calibration and maintenance (Blue Mountain, Calibration Management Software) * GMP oversite of on-site small-scale Pilot Plant/Cleanroom) * 2001 Outstanding Achievement Award - Collagen Preclinical Development

* Non-GMP manufacturing of Combinatorial Chemistry libraries for drug discovery partners * Implementation of Total Quality Management (TQM) to ensure quality in all aspects of the division's operations * Document Control Manager (paper-based system) * Materials Management oversight, including the creation of a custom bar-coding systems for raw materials and components * Wrote all departmental SOPs * Implementation of quality systems including document management and retention, synthesis protocols, deviations, CAPA, internal audits, and product & customer complaints * Facilitator, Material Review Board * Production equipment and software validation, writing and performing IQ, OQ, and PQ's with the validation team * Technology transfer and training program Manager (Daiichi Pharmaceuticals, Japan)

* Non-GMP manufacturing of Combinatorial Chemistry "libraries" for drug discovery partners * Shared team responsibility in all phases of high throughput parallel solution-phase synthesis for the production of a 100,000 compound library for Johnson & Johnson and additional smaller scale libraries for various customers * Maintenance of small molecule database and report generation (ISIS Base 1.2) * Interfaced with internal high-throughput screening group * Quality Control of finished product by MS, LC/MS, HPLC, and NMR * Provided internal training on equipment and procedures * Cold Chain Management (-80C storage and shipping requirements) * Collaborated on the development and validation of custom-designed Bohdan robotic systems for synthesis, extraction, delivery, and plating of libraries

Providing GxP Quality Systems and Compliance consulting services for short and long-term projects globally.