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

MANAGER (GROUP LEADER, TEAM LEADER) ASEPTIC FILLING MAY 2004 – PRESENT

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.

 

CHEMIST AUGUST 2003 – MAY 2004
  • 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

 

CHEMIST JULY 2001 – AUGUST 2003
MAY 1996 - JULY 1998
  • 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 

 

CHEMIST JULY 1998 – AUGUST 2001
  • 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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