Experienced Supervisor

Katherine Karl

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*** ***** *** *** ** Canton, KS 67428 620-***-****

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Career

Summary Wide range of knowledge in packaging process, manufacturing process and the quality system

Experienced Supervisor Developed Employees Manufacturing Proficient

Six Sigma – Green Belt Aseptic Department Trainer Project Coordinator

Created Training Programs FDA Regulations Specialist Culture Initiative

Performance Management Quality Assurance Expert Strong Detail Orientation

Professional

Qualifications

Professional

Experience 2001-2007 Hospira, Inc. Aseptic Core Monitor, Aseptic Sanitation Supervisor

Aseptic Core Monitor Supervisor/Aseptic Sanitation Supervisor

• Responsible for educating and training over 100 personnel in compliance with Current Good Manufacturing Practices and plant requirements

• Supervisor and facilitated during critical time frame taking over 20 individual controlled areas from an controlled area to maintenance conditions and returning back to operating condition

• Certified co-team leader for Six Sigma Green Belt project to sterilize silicone into the aseptic corridors, project is projected to reduce labor and material cost.

• Certified co-team leader for Six Sigma Green Belt to reduce alcohol usage in the facility to meet environmental health and safety requirements

• Aided in the design of an aseptic training area utilized to simulate aseptic gowning and technique

• Aseptic representative for Six Sigma Black Belt project to reduce environmental excursions in all aseptic and controlled areas.

• Implemented tracking system through ISOtrain to ensure all aseptic personnel participated in semi annual aseptic media validation

• Revised standard operating procedures and training course plans to maintain compliance with Current Good Manufacturing Practices

• Coordinated all bi-annual media simulations

• Provided production support of media simulations

• Provided information and guidance for contamination control and air reversals

• Wrote containment plans for the facility and outside contract organizations

• Restructured aseptic service workers organization to improve resources allocation labor

• Supervised 14 non- exempt employees

• Reviewed production reports, engineering validation report, silicone log sheets, alcohol log sheets and environmental log sheets

• Wrote environmental out of specification results

Quality Assurance Auditor--- Daily responsibilities include:

• Prepared daily audit report setups and reviewed

• Proficient in QA line clearance, light test, and observation of packaging procedure

• Knowledgeable in pulling and storing of QA Reserve Samples, as well as, stability and sterility Samples

• Communicated with production regarding Quality issue Use of AQL Side rule for sampling plan

• Expert in database entry and trend analysis in Paradox

• Specialist with the use of QAL Slide rule for sampling plans

• Monitored, reviewing, and follow up of product storage charts

• Performed Reserve Monthly Examination and Destruction

• Initiated On Hold and Foreign Material Status Labeling

Pharmaceutical Assistant--- Daily responsibilities included:

• Certified Dabrico, horizontal, ampul, and vial light tester

• Knowledgeable in the Non-printed/printed material components check in process

• Professional in Pre/post room purges

• Skilled with packaging procedures for vial/bottles, ampul, and cartridges

• Qualified in production label hourly check operator

2000-2001 Assistant Manager for T&E Oil Company

Assistant Manager--- Daily responsibilities included:

• Supervised and facilitated employees; Established and enforce daily job responsibilities

• Managed inventory control; accounting, stock inventory, count and order necessary inventory

• Establishing public relations

• Responsible for managing daily bookkeeping

• Organized and prepared weekly Scheduling

1997-2000 Shift Manager for Pizza Co.

Shift Manager--- Daily responsibilities included:

• Supervised employees; Established and enforced daily job responsibilities

• Managed inventory control; accounting, stock inventory, count and order necessary inventory

• Established public relations

• Responsible for managing daily bookkeeping

• Maintained and provided an accurate balance cash register

• Managed and facilitated sanitation control

• Prepared and stocked salad bar daily

• Managed and monitored daily preparation requirements

• Provided staffing coverage when shorthanded in all areas

1990-1995 Operator in 3 departments at Certainteed

Operator--- Daily duties included:

• Responsible for set up and color changes

• Expert in safety inspections

• Responsible for delegating cleaning duties

• Facilitated break relief for personnel

• Managed all production tickets

• Drove forklift and move product

• Attended production meetings

• Prepared line for production

• Knowledge of quality assurance for every product

Education Fall 2007- Current Friends University Wichita, Ks

Bachelors Program OML anticipated graduation date October 2008

2004-2007 Friends University Wichita, KS

Associate’s Degree in General Studies GPA 3.26.

References Available upon request

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