Joanna Rafalowicz

** **** ** *** *******, CT ****3 860-***-**** acszxf@r.postjobfree.com

SUMMARY

An Analytical Scientist/Lead with extensive experience in Reagent Manufacturing and Quality Control environment. More than 9 years of experience operating in a GMP/GLP/ISO 9001 certified environment with frequent exposure to ISO 13485 requirements, including six years as a lead/back up supervisor for manufacturing and quality control laboratory. Comprehensive experience in, process improvement, quality control, biology, chemistry, statistics, and running a well-organized, highly efficient lab schedule and team. Fluent in Polish.

TECHNICAL SKILLS

Computer: MS Word, PowerPoint, Access, and Excel, Outlook, SAP, Minitab, Adobe Acrobat

Laboratory Instruments: Accuri Flow Cytometer C6, Beckman Coulter Counter Multisizer 3, Perkin Elmer and

Shimadzu UV/VIS Spectrophotometer, Qiagen Pyromark Pyrosequencer, CASY Counter and Analyzer, Agilent 2100

Bioanalyzer HPLC, Atomic Absorption Spectrometer, Thermocycler, Molecular Devices and Synergy Plate

PROFESSIONAL EXPERIENCE

Roche Applied Science, 454 Life Sciences, Branford, CT 2006 - 2015

Quality Control Analyst III / Supervisor Back-up (Aug 2012-May 2015)

Analyze raw materials and manufactured products to confirm that they meet company and customer specifications using a variety of enzymatic assays, DNA sequencing, and other analytical techniques, like small chemical testing using the HPLC, following standard operating procedures.

Continuously work on troubleshooting and special projects to facilitate and support process improvement.

Compile data and document the test procedure results for quarterly review using Minitab. Report and investigate any data that is not in compliance to specifications and shows any variances.

Create, revise and update standard operating procedures for quality control and instrument manufacturing departments.

Create and update nonconforming and out of specification reports for quality control and instrument manufacturing departments.

Inspect instrument manufacturing department and all their incoming, finished parts as well as totally assembled instruments according to standard operating procedures.

Verify that all laboratory instruments are maintained and calibrated as scheduled.

Participate and maintain all laboratories to a 5S principle.

Schedule analysts for daily product testing to meet company production schedule using the SAP system

Collaborated with other departments and vendors to ensure proper inventory consumables are on hand for all manufacturing departments.

Sr. Manufacturing Associate/ Team Lead, Supervisor Back-up (Jan. 2011 – Aug 2012)

Manufacturing Associate III / Team Lead (Jan 2008 – Dec 2010)

Manufacturing Associate II (Jan 2007 – Dec 2008)

Manufacturing Associate I (Jan 2006 – Dec 2007)

Planed, led, scheduled associates and product production to meet the company’s production schedule as well as led and performed special team projects

Held daily team meetings to review the scheduling

Developed and implemented Value Stream mapping for all of Critical Components materials that resulted in creating standardized work time for all these items that is still used today

Tracked the team deliveries, performance and training. Reviewed results in graph form with supervisor.

Chosen as a member of the Critical Components reagent manufacturing team to timely deliver high quality bead products and bead reagent consumables for use on 454 Life Sciences Genome sequencers. This was done by performing PCR amplification on DNA sequences, bind DNA sequences to protein beads and determined DNA concentrations, purity and enzymatic activities using various assays.

Followed standard operating protocols and maintained chain of custody

Provided support for new product development, scale up process from R&D to manufacturing and worked on ongoing process improvement as well as quality/process/product troubleshooting.

Maintained inventory with the SAP system, followed current standard operating procedures, executed documents pertaining to production, instrument calibration, and perform necessary repairs on equipment in order to maintain optimum performance.

Trained new and existing group members to perform the aforementioned responsibilities in addition to necessary protocols.

Hartford Hospital

Patient Administrative Associate 10/2000 -12/2003

Ordered multiple tests and consults.

Transcribed doctor orders.

Worked on Sunrise and SMS clinical systems.

Human Resources Associate

Supported the Medicine, Cardiology and IS departments in all Human Resources aspects.

EDUCATION

Bachelor of Arts, University of Connecticut 1996 - 2000

Major: Communication Disorders

Bachelor of Science, University of New Haven Matriculate

Major: Forensic Science (Internship /project completion)

CERTIFICATIONS AND ADVANCED TRAININGS

HPLC Advanced Training

Lean Six Sigma Yellow Belt Certificate

Roche constructed “Design for Quality and Manufacturability (DQM)” Training with focus on Capability and Control and Design of Experiments Training

Problem Solving and Corrective Action Training

Managing Multiple Projects, Objectives and Deadlines Training

Effective Technical Writing Training

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