Sheila Wright

**** **** **** ******

KCMO *****

***/***-**** (Home)

***/***-**** (Cell)

acwcpv@r.postjobfree.com

Objective

To obtain a challenging and rewarding position in the Pharmaceutical industry that will allow me to utilize my thirty plus years of experience, knowledge and skills in the field of Pharmaceutical Manufacturing.

Catalent

September 2014 - Present

Production Supervisor

Scheduled, planned daily work activities.

Review completed production batch records for accuracy.

Provide technical support for packaging employees.

Oversee multiple production work areas and employees.

Train production personnel to follow GMP’s and safety regulations.

Conduct annual employee’s evaluations.

Manage all compliance/safety training requirements for the packaging team.

Ensure packaging team complete all required training.

Perform all gowning training for the Css groups.

Conduct monthly compliance audits.

Work with clients regarding, client complains.

Approve Bi-weekly time cards in payroll system.

Dimensional Innovations, Merriam Lane, Overland Park

Custodial technician, February 2011 – 2014 (Part-Time)

Oversee multiple work areas.

Clean building floors by sweeping, mopping, scrubbing, or vacuuming them.

Gather and empty trash.

Service, clean, and supply restrooms.

Evaluate and justify supplies, equipment, and purchases as needed.

Maintain an environment that is sanitary, attractive, and in orderly condition.

Notify managers concerning the need for major repairs.

Bayer Animal Health, Shawnee, KS

Training Specialist, April 2004 – December 2010

Planned and coordinated regulatory cGMP training for the site.

Developed, Delivered implemented and managed strategic regulatory & technical training.

Developed interesting and enthusiastic training courses to meet the increasing regulatory and technical requirements.

Managed training documentation system to assure that training data was secure, complete, accurate and readily available for inspections and internal and external audits.

Managed training resources to assure that customer’s needs were met or exceeded.

Serve as Product Supply liaison/ facilitator for the Animal Health training and CIP programs.

Obtained and maintain required certifications and qualifications to conduct various training and development interventions.

Participated in audits by regulatory agencies as required.

Partnered with external support resources to facilitate the growing company relationship with government funding sources (KIR & KIT).

Managed, developed, and monitored training budget, using SAP and Copla for the department.

Negotiated training contracts with external vendors.

Bayer Animal Health, Shawnee, KS

Supervisor manufacturing, sterile filling, October 2001 - April 2004

Managed, coordinated and entered all raw material and labor usage into SAP.

Scheduled, planned, and directed activities, assigned personnel, assured material availability, and coordinated with other areas to assure that production requirements were met with high levels of quality, safety, and cost efficient productivity.

Provided technical knowledge related to sterile processing for use in other departments and worked with technical staff in those areas to make improvements and solve problems.

Created Standard Operating Procedures and Batch Production Records, provided input for documents created for other departments.

Trained and motivated personnel in highly specialized disciplines, including aseptic processing, GMP’s and safety.

Reviewed completed production records for accuracy and helped process them. Reviewed environmental monitoring trends.

Created job descriptions: conducted annual evaluations of personnel, counseled, hired, interviewed, and disciplined personnel as needed.

Scheduled and coordinated area activities with other departments to assure a smooth flow of complex interactions such as validation projects or new product introduction/pilot batches. Provided technical expertise as appropriate.

Constant involvement in problem-solving situations.

Investigation of contamination events in the aseptic core and formulated corrective actions.

Bayer Animal Health, Shawnee, KS

Sterile Filling Specialist, March 1999 - October 2001

Set-up, operation, tear down and cleaning of sterile filling equipment and processes.

Cleaned and sanitized sterile filling suites and equipment. Supported areas within the parental manufacturing complex.

Followed and adhered to all departments SOP’s, batch records, and cGMP’s and OSHA requirements.

Education

Paseo High School, Kansas City, MO

1976 – 1980

Diploma

Penn Valley College, Kansas City, MO

1987 - 1989

Completion approximately 18 credit hours

General Biology 1

Institute at Maple Woods College, Kansas City, MO

1989 – 1992

Certified as Animal Technician

Train the Trainer certified (ASTD).

Operational Excellence Training

Sap Training

DOT certified (DGAC)

Computer Skills

MS Excel, MS Word, MS PowerPoint (basics), MS Internet Explorer, Outlook Express, SAP, Lotus Notes, Registra, Plateau, Copla, Kaplan EduNeering, Production Development program database,

Concur, and trackwise.

Awards

Attendance

Special Recognition Award – Team Effort

Employee of the month

References:

Tim Weyrauch, Bayer Team Lead: 913-***-**** (office), 913-***-**** (cell)

Jonathan Frucci, Bayer supervisor: 303-***-**** (cell)

Allison Schmitt, Dimensional Innovations: 913-***-**** (office)

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