Regina Cagnina

** *********** ***** 585-***-****

Rochester, New York, 14621 ac0dem@r.postjobfree.com

Summary of Qualifications

Hard working, diligent, tenacious QA Chemist with over twenty years of successful experience in Wet Chemistry, High Performance Liquid Chromatography(HPLC), Gas Chromatography(GC) and other Industry Specific testing in laboratories of a variety of industries. Thorough technical knowledge coupled with outstanding interpersonal and organizational skills and an ability to adapt makes for an enthusiastic team player. The technical experiences extend to several instruments specific software packages as well as Windows based software.

Laboratory Environments: Chemical, Pharmaceutical, Contact Lenses, Polymer Chemistry, Biomedical and Environmental

Proven Expertise:

Training/Mentoring Time Management

Technical Problem Solving Systems Improvement

Multi-Tasking Procedure and Protocol Development

cGMP/GLP Record Keeping Analytical Thinking

Team Player Methods Improvement

Performance Excellence Yellow Belt Certified

Professional Experience

Ortho Clinical Diagnostics

(Contract, Analytical Laboratory)

Scientist II

Back-fill for the Analytical Laboratory supervisor. Duties include: Attending meetings for planning and scheduling. Participate in peer review of site wide non-conformances. Supervise day-to-day laboratory operations. Project management of qualifications/validations of laboratory equipment by laboratory personnel. Supervisory review and sign-off of laboratory investigations. Well versed in software applications; SAP, OTIS, Ariba and Crossroads Trackwise systems. Participation in continuous improvement projects for the laboratory and other areas of manufacturing.

Bausch + Lomb

(Contract, Research and Development)

Polymer Chemist

Duties include: Formulation of experimental monomer mixes and preparation of experimental sample contact lenses. The development and execution of experiments with the co-operation of project managers. To obtain, submit for testing and organize important raw material quality documents for pre-clinical or clinical batches of experimental contact lenses, inventory management of raw materials with ChemSW CisPro software.

Lonza, Inc, Rochester, New York

(Chemical Manufacturing)

QA Technician

Duties included; to assisting in an HPLC method transfer, troubleshooting and procedure developing. I was responsible for the ordering and delivery of a new HPLC. Learned and trained others on the latest version of the Waters Empower© software. Responsible also for updating and improving all the HPLC methods for the QA/QC department.

UCB Manufacturing, Rochester, New York

(Pharmaceutical and Biomedical Company)

QA Chemist

Performed the testing and release of pharmaceutical samples in the stability program. Testing included Wet Chemistry testing such as pH, release rate testing and friability. Testing also included purity determination by HPLC and Ultra Violet-Visible(UV-Vis) Spectral Analysis. Additional duties included: the organization of pre-printed standard books and calibration and maintenance of laboratory equipment. Responsible for the training other analysts on new products and analytical techniques.

Delivered cost reduction in the purchasing of bulk inline filters without compromising quality.

Identified and proposed and delivered on automating drug release testing for particular drugs.

Carried out engineering protocol to determine the feasibility of a change to the drug closure system of a particular drug.

Accomplished the methods transfer of a drug dosage form from California location to Rochester site.

Bausch and Lomb, Rochester, New York

(Contact Lens Manufacturer)

Monomer Laboratory Technician

Responsibilities included the formulation of contact lens monomer, distillation of raw materials for monomer production. The analytical testing of raw materials and finished blends by GC, HPLC, UV-Vis and Infrared Spectrophotometry (IR). Additional duties included improvements in content and clarity of written standard operating procedures.

Chemical Technician III

Responsibilities included stability testing of othamic solutions by HPLC. The testing of contact lens and raw materials for release by GC. I provided contact lens engineering/pilot laboratory support. Keep a laboratory notebook in keeping with cGMP/GLP guidelines. Well versed in use of Agilent ChemStation software.

Developed preventative maintenance schedules for the analytical instrumentation.

Assumed a leadership role in troubleshooting equipment to ensure and engineering project meet a required deadline.

A member of the site wide safety committee.

Bristol-Myers Squibb, Syracuse New York (Pharmaceutical)

Laboratory Technician (Quality Services and Worldwide Technical Services(WTS))

Responsibilities included routine analysis of antibiotic process streams by GC and other USP required testing. In WTS, responsibilities included providing technical support for the Quality Control departments. Also, the development, validation and submission of HPLC methods for New Drug Applications. Projects included methods improvements for cost cutting initiatives using new technologies. Extensive experience with Waters Millennium software.

Development and validation of a new procedure for submission in a New Drug application for synthetic Taxol.

Cost saving initiative utilizing a refrigeration unit on an HPLC to lengthen expiry times and cut man hours.

Developed analytical method for determination of an impurity profile of a well established antibiotic.

Education

Nazareth College of Rochester, Rochester, New York

Bachelor of Science - Biochemistry

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