Packaging Supervisor - Candidate JS 062717

• B.S., Natural Sciences w/Chemistry Emphasis
• 13 years of experience in Supervision, Management, Aseptic Filling, and hiring staff members
• Strong Leadership and Management - conducts team meetings, currently managing 70 direct reports
• Working with USDA and European Union regulations
• Significant experience writing SOPs and SSOP's, plans production requirements for 5 fill lines
• Project lead for installation of WFI Diluent filling system
• Currently works with fill lines up to 300 per minute
• Sounds smart, vibrant and genuine, looking for growth and opportunity in her next position
• Open to relocation, house to sell, her and her 24 year old son will move

I am seeking a career where I can use my experience and education to help the company meet and surpass its goals.

• Proactive and results-oriented in vaccine manufacturing and production supervisor with 12+ years of experience overseeing all teams and operations to ensure accuracy, quality, and safety within high-volume, challenging vaccine manufacturing.
• Efficient prioritizing, organizing and multi-tasking skills developing process improvements, implementing new procedures, focusing on safety, and implementing corrective actions to prevent reoccurring deviations.
• 10+ years’ experience using various computer programs (Trackwise, AS400, SAP, MAPICS, IdeaforCon) for SOP revisions, deviations, CAPA’s, change controls, and item inventory.
• Proficient in cGMP manufacturing, USDA and EU Regulations, following SOP’s, and working in a sterile environment.

EXPERIENCE

Earning $98K, plus 15% bonus.

• Responsible for 17 staff employees and 47 union employees.
• Responsible for maintaining department operating budget of 4+ million.
• Maintain cGMP, USDA, and EU compliance for areas of responsibility. Perform and participate in internal and external audits.
• Developing weekly schedules based on production needs.
• Supervise production activities for Aseptic Filling: including three EU filling lines, two USDA filling lines, 5 lyophilizers, and syringe filling.
• Responsible for maintaining all BOM’s, item numbers, process records, product costing information, area inventory, and budget planning.
• Coordinate facility and equipment maintenance and calibration activities with manufacturing schedule.
• Proficient in creation, managing, and execution of Change Control.
• Responsible for updating department SOP’s, forms, and executing CAPA plans.
• Work closely with Validation Department to qualify new lyo cycles, cleaning cycles, autoclave cycles, and aseptic filling processes.
• Elected for a member of product transfer team: Develop new production process from other company’s manufacturing instructions, creating new BOM’s, item numbers, process records, equipment needs and completing (3) process development runs for each product.
• Responsible for developing URS’s for new equipment, providing new equipment requirements and components, and assisting engineering with implementation.

Happy with currently place of employment, seeking new opportunities at her leisure.

• Perform batch testing per established procedures using pH meters, UV analysis and various wet chemistry testing.
• Collect samples from the production floor for testing.
• Responsible for reformulation calculations for batches with failing testing results.
• Work with R&D to test small scale production batches

• Perform testing on various products using USP/EP/JP guidance.
• Develop new testing procedures using HPLC/GC/UV.
• Responsible for manufacturing required reagents for laboratory testing.
• Organize and lead team for ORS testing which included pipetting, titrations, and AA analysis for metals 

• Perform testing on various products using USP/EP/JP guidance.
• Back up to laboratory manager when needed.
• Responsible for audit compliance with customers and KDHE
• Perform microbiological counts using filtration.

EDUCATION

Missouri Western State University Saint Joseph, MO

Bachelor of Science degree in Natural Sciences w/Chemistry Emphasis/Biology Minor May 1996

ACCOMPLISHMENTS/PROJECTS

• Participant on multiple product transfer teams
• FAT, SAT, qualification of new filling equipment for building expansion
• Project lead for installation of WFI Diluent filling system
• Member of development team for Vaccine Production SAP system, develop template and rollout new system, provide training as a Key User
• Design, install, and implement the Shopvue Shop Floor Program
• Successful completion of Aseptic Processing Training Course at the University of Tennessee
• Successful completion of the Management and Leadership Development Program (MLDP)

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