R Wronkiewicz Lab Resume
Raymond F. Wronkiewicz
344 South Edgelawn Drive
Aurora, Illinois 60506-4545
Cell phone: ------------
email: ------------
Education
BA Biology (Undergraduate work includes 21 Sem. Hrs. in Chemistry and 7 Sem. Hrs. in Statistics). Aurora University, Aurora, Illinois
42 Sem. Hrs. earned toward a MS in Environmental Biology (GPA 3.63/4.00). Governors State University, University Park, Illinois
Professional Summary
• Over 25 years’ experience with chemical and biological analysis using EPA, APWA/AWWA/WPCF, ACS, USP and AOAC methods.
• Experienced includes the operation and maintenance of instrumentation including HPLC, GC, ICP, AA, UV/Vis, FTIR, pH, etc.
• I was officially listed on IEMA site licenses as a user of radioactive material.
• I was a member of a hazardous material response team for several firms.
Experience
Quality Manager: 8/2015 to present, Quality Control Department. CCL Healthcare, 1862 Suncast Ln., Batavia, Illinois 60510.
• Responsible for the overall management and oversight of all plant Quality Control activities for the Batavia, IL facility.
• Develop, review and approve all validation protocols for the Batavia, IL facility.
• Lead auditor for the CCL Batavia, IL facility audits from outside interests.
• Perform internal facility audits and travel as required in support of the CCL QMS.
Quality Associate III, 10/07 to 6/2015, Corporate Quality/Global Field Surveillance/Field Corrective Actions, Baxter Healthcare. 25212 W Il Route 120, Round Lake, Illinois 60073.
• Was the Baxter contact for multiple FDA District offices to submit regulatory agency notifications and status reports; Participate in internal and external inspections and assist with implementing solutions to audit findings. Verify FCA monthly status reports to the FDA.
Quality Engineer/Quality Assurance Supervisor: 12/05 to10/07, Quality Assurance Department, Bard Brachytherapy, Inc., 295 E Lies Rd., Carol Stream, Illinois. 60188
• Listed on IEMA site license as a Radioactive Material User.
• Used USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Performed quality-engineering functions and associated tasks in support of C.R. Bard business objectives. Identified, implemented, and monitored procedures and systems to support 21CFR§820 and 803, ISO 9001-134855, and the European Medical Device Directive MDD. Ensured compliance to Carol Stream and corporate procedures.
• Was accountable for overall compliance administration activities relating to Validations/Qualifications, and CAPA.
• Supervised both shifts of the QA lab and order release personnel.
• Developed and modified test methods and appropriate inspection procedures and protocols.
• Ran the equipment Calibration Program.
• Created and reviewed protocols, process and product validations, and test methods. Evaluated manufacturing quality and yield issues and drives corrective action. Reviewed and approved changes to procedures and specifications.
Quality Control Laboratory Technician: 7/93 to 9/05, QC Department, GE Healthcare (also DBA as Amersham Healthcare & Med+Phisics Inc.)3350 N Ridge Ave., Arlington Heights, Illinois.
• Listed on IEMA site license as a Radioactive Material User.
• Used USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experience with the operation and maintenance of instrumentation including HPLC, pH, etc.
• Was involved with the development and compliance of laboratory and general facility safety programs including air quality.
• I was a member of a hazardous material response team.
Analytical Chemist: Technical Operations Department, 3/92 to 7/93, Alberto-Culver Company, 2525 Armitage Ave, Melrose Park, IL 60160
• Developed, modified and validated analytical procedures.
• Used APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• I was a member of the hazardous materials response team.
• Validated laboratory equipment
Environmental Chemist: Temporary contracted analytical chemist at the Mobile Oil Refinery in Joliet through Lab Support, Inc. 1/91 to 3/92, 9450 Bryn Mawr Ave., Ste 340, Rosemont, IL 60018
• Used EPA APWA/AWWA/WPCF, ACS and AOAC methods to test water discharge from the refinerty.
• Experienced with the operation and maintenance of instrumentation including GC, UV/Vis, IR, AA, pH, etc.
Manager, Analytical Chemistry Laboratory: 3/88 to 9/90, QC Chemistry Department, LyphoMed Inc., 2020 Ruby St., Melrose Park, IL 60160.
• Managed a 3 shift, 32-member analytical chemistry lab with 4 supervisors, $1.4 million operation budget and signing authority to $1,000.
• Adapted USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods to facility requirements.
• Participate in audits from regulatory agencies (FDA, BSI, OHSA, IEMA, MPSD, etc.). Work with federal, state and international regulatory agencies.
• Identified, developed, implemented, monitored and maintained procedures and support systems to cGMP maintain compliance.
• Experienced in the application of statistical methods to both scientific and business operations.
• Experienced with facility management. Planned and supervised laboratory remodeling and expansion projects.
• Performed internal audits and traveled as required in support supplier Quality System Audits. With the supplier Quality function, acts as liaison to suppliers relative to Quality issues and SCARs.
• I was a member of the hazardous materials response team.
• Perform performance reviews on subordinates.
Supervisor, Quality Control Laboratory: 1/87 to 3/88, QC Department, Cloud Corporation/Proctor and Gamble, Inc., 2475 S Wolf Rd., Des Plaines, IL 60018.
• Managed an 8-member analytical chemistry lab in support of a Proctor and Gamble pilot manufacturing plant operation.
• Used and adapted APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including UV/Vis, IR, AA, pH, etc.
• Planned and supervised laboratory remodeling and expansion projects.
• I was a member of the hazardous materials response team.
• Perform performance reviews on subordinates.
Analytical Chemistry Technician: 3/82 to 1/87, Quality Control Laboratory, The NutraSweet Co., G.D. Searle, Inc. 2601 Bond Street, University Park, IL 60466.
• Used and adapted USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including HPLC, GC, UV/Vis, IR, AA, pH, etc.
• I was a member of the hazardous materials and firefighting response teams.
Environmental Research Technician: 6/79 to 3/82. Environmental Research Division, Texas Instruments, Inc., Chicago Regional Office, 28w620 Indian Knoll Rd., West Chicago, Illinois 60185.
• Biological, chemical and physical sampling and analysis of Midwestern land and water sites using APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including UV/Vis, IR, pH, etc.
Professional Affiliations
• Association of Official Analytical Chemists
• Illinois Association of Environmental Professionals
• American Society for Quality Control
Raymond F. Wronkiewicz
344 South Edgelawn Drive
Aurora, Illinois 60506-4545
Cell phone: ------------
email: ------------
Education
BA Biology (Undergraduate work includes 21 Sem. Hrs. in Chemistry and 7 Sem. Hrs. in Statistics). Aurora University, Aurora, Illinois
42 Sem. Hrs. earned toward a MS in Environmental Biology (GPA 3.63/4.00). Governors State University, University Park, Illinois
Professional Summary
• Over 25 years’ experience with chemical and biological analysis using EPA, APWA/AWWA/WPCF, ACS, USP and AOAC methods.
• Experienced includes the operation and maintenance of instrumentation including HPLC, GC, ICP, AA, UV/Vis, FTIR, pH, etc.
• I was officially listed on IEMA site licenses as a user of radioactive material.
• I was a member of a hazardous material response team for several firms.
Experience
Quality Manager: 8/2015 to present, Quality Control Department. CCL Healthcare, 1862 Suncast Ln., Batavia, Illinois 60510.
• Responsible for the overall management and oversight of all plant Quality Control activities for the Batavia, IL facility.
• Develop, review and approve all validation protocols for the Batavia, IL facility.
• Lead auditor for the CCL Batavia, IL facility audits from outside interests.
• Perform internal facility audits and travel as required in support of the CCL QMS.
Quality Associate III, 10/07 to 6/2015, Corporate Quality/Global Field Surveillance/Field Corrective Actions, Baxter Healthcare. 25212 W Il Route 120, Round Lake, Illinois 60073.
• Was the Baxter contact for multiple FDA District offices to submit regulatory agency notifications and status reports; Participate in internal and external inspections and assist with implementing solutions to audit findings. Verify FCA monthly status reports to the FDA.
Quality Engineer/Quality Assurance Supervisor: 12/05 to10/07, Quality Assurance Department, Bard Brachytherapy, Inc., 295 E Lies Rd., Carol Stream, Illinois. 60188
• Listed on IEMA site license as a Radioactive Material User.
• Used USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Performed quality-engineering functions and associated tasks in support of C.R. Bard business objectives. Identified, implemented, and monitored procedures and systems to support 21CFR§820 and 803, ISO 9001-134855, and the European Medical Device Directive MDD. Ensured compliance to Carol Stream and corporate procedures.
• Was accountable for overall compliance administration activities relating to Validations/Qualifications, and CAPA.
• Supervised both shifts of the QA lab and order release personnel.
• Developed and modified test methods and appropriate inspection procedures and protocols.
• Ran the equipment Calibration Program.
• Created and reviewed protocols, process and product validations, and test methods. Evaluated manufacturing quality and yield issues and drives corrective action. Reviewed and approved changes to procedures and specifications.
Quality Control Laboratory Technician: 7/93 to 9/05, QC Department, GE Healthcare (also DBA as Amersham Healthcare & Med+Phisics Inc.)3350 N Ridge Ave., Arlington Heights, Illinois.
• Listed on IEMA site license as a Radioactive Material User.
• Used USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experience with the operation and maintenance of instrumentation including HPLC, pH, etc.
• Was involved with the development and compliance of laboratory and general facility safety programs including air quality.
• I was a member of a hazardous material response team.
Analytical Chemist: Technical Operations Department, 3/92 to 7/93, Alberto-Culver Company, 2525 Armitage Ave, Melrose Park, IL 60160
• Developed, modified and validated analytical procedures.
• Used APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• I was a member of the hazardous materials response team.
• Validated laboratory equipment
Environmental Chemist: Temporary contracted analytical chemist at the Mobile Oil Refinery in Joliet through Lab Support, Inc. 1/91 to 3/92, 9450 Bryn Mawr Ave., Ste 340, Rosemont, IL 60018
• Used EPA APWA/AWWA/WPCF, ACS and AOAC methods to test water discharge from the refinerty.
• Experienced with the operation and maintenance of instrumentation including GC, UV/Vis, IR, AA, pH, etc.
Manager, Analytical Chemistry Laboratory: 3/88 to 9/90, QC Chemistry Department, LyphoMed Inc., 2020 Ruby St., Melrose Park, IL 60160.
• Managed a 3 shift, 32-member analytical chemistry lab with 4 supervisors, $1.4 million operation budget and signing authority to $1,000.
• Adapted USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods to facility requirements.
• Participate in audits from regulatory agencies (FDA, BSI, OHSA, IEMA, MPSD, etc.). Work with federal, state and international regulatory agencies.
• Identified, developed, implemented, monitored and maintained procedures and support systems to cGMP maintain compliance.
• Experienced in the application of statistical methods to both scientific and business operations.
• Experienced with facility management. Planned and supervised laboratory remodeling and expansion projects.
• Performed internal audits and traveled as required in support supplier Quality System Audits. With the supplier Quality function, acts as liaison to suppliers relative to Quality issues and SCARs.
• I was a member of the hazardous materials response team.
• Perform performance reviews on subordinates.
Supervisor, Quality Control Laboratory: 1/87 to 3/88, QC Department, Cloud Corporation/Proctor and Gamble, Inc., 2475 S Wolf Rd., Des Plaines, IL 60018.
• Managed an 8-member analytical chemistry lab in support of a Proctor and Gamble pilot manufacturing plant operation.
• Used and adapted APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including UV/Vis, IR, AA, pH, etc.
• Planned and supervised laboratory remodeling and expansion projects.
• I was a member of the hazardous materials response team.
• Perform performance reviews on subordinates.
Analytical Chemistry Technician: 3/82 to 1/87, Quality Control Laboratory, The NutraSweet Co., G.D. Searle, Inc. 2601 Bond Street, University Park, IL 60466.
• Used and adapted USP, APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including HPLC, GC, UV/Vis, IR, AA, pH, etc.
• I was a member of the hazardous materials and firefighting response teams.
Environmental Research Technician: 6/79 to 3/82. Environmental Research Division, Texas Instruments, Inc., Chicago Regional Office, 28w620 Indian Knoll Rd., West Chicago, Illinois 60185.
• Biological, chemical and physical sampling and analysis of Midwestern land and water sites using APWA/AWWA/WPCF, ACS, EPA and AOAC methods.
• Experienced with the operation and maintenance of instrumentation including UV/Vis, IR, pH, etc.
Professional Affiliations
• Association of Official Analytical Chemists
• Illinois Association of Environmental Professionals
• American Society for Quality Control