Quality Assurance Customer Service

KEVIN AMENT

**** ******** ******, ******, ** ****8 • 952-***-****, cell - 612-***-****• *******@****.***

SUMMARY

Dynamic, highly-motivated and results-driven management professional with over 22

years of transferable experience within the pharmaceutical and manufacturing

industries. Proven track record of superior performance and increasing profitability.

Outstanding ability to communicate and motivate team members to enhance strategic

goals and bottom line objectives. Resourceful individual with the ability to

build/maintain relationships and complete projects producing professional results while

adhering to rigid deadlines. Focused on improving production processes yields,

eliminating process errors, and leveraging employee productivity, with an emphasis on

quality and safety assurance.

COMPETENCIES

• CORE

Excellent business communication, organizational and interpersonal skills

Comprehensive knowledge of writing quality systems documentation

Strong ability to generate and comprehend data on a technical and compliance level

Problem solver with the ability to learn quickly, analyze information and deliver solutions

EXPERIENCE

• PROFESSIONAL

CIMA LABS, Eden Prairie, MN 1998 - present

Associate Director, Production (2008 - present)

Oversaw manufacturing and packaging departments in two locations, directing two production

managers who supervised more than 65 production operators spanning three production shifts.

Reviewed, updated and implemented SOPs, operational processes and procedures to improve

productivity, quality, efficiency, and to ensure compliance with cGMP standards and regulatory

requirements.

Performed staffing duties including: dealing with under staffing, refereeing disputes, training,

hiring/firing employees, conducting employee evaluations, and administering corrective

actions. Utilized TrackWise (quality management software) to ensure corrective and preventative

actions were implemented to resolve problems and changes to procedures.

Responsible for all efficiency and RFT metrics measurements including yields, scrap loss, safety,

customer service, GMP and FDA compliance

Inspected work performed by staff to guarantee specifications were met, standards were

established and to target/eliminate excess manufacturing and packaging overhead costs.

Responsible for managing operational budget, writing production reports, performing internal

audits, and ensuring department wide compliance with FDA, MHRA, OSHA, and DEA regulations.

Key Accomplishments

Chosen to be the interim Director of Production at the SLC Teva manufacturing facility from March

thru November 2012 to complete the technical operations transfer from the Cima Eden Prairie site.

Successfully managed a $4.4 million departmental budget.

Production Manager Compression Packaging (2004 - 2008)

Responsible for efficient packaging of all commercial, R&D, and Engineering process orders in the

manufacturing departments at two manufacturing locations, overseeing 50 machine operator

positions including a supervisor team of 6.

Monitored the production process, worked directly with product partners to resolve

manufacturing related issues, adjusted production schedules as needed, and assured quality

standards were being met.

Conducted investigations into production anomalies and unexpected laboratory results;

coordinating with quality assurance and quality control groups.

Authored SOPs and CAPAs in response to processing and quality observations.

Responsible for employee development, training, disciplinary actions, and performance reviews.

Key Accomplishments

Successfully managed a $2.5 million departmental budget.

KEVIN AMENT

EXPERIENCE CONTINUED

• PROFESSIONAL

CIMA LABS, Eden Prairie, MN

Production Supervisor/Training Engineer (1998 - 2004)

Responsible for all production shift activities including batch record review and release .

Trained employees on machinery operations, cGMP standards, SOPs, and FDA regulations.

Assisted plant manager with staffing issues and FDA compliance audits.

Key Accomplishments

Selected as the Employee of the Year in 2000.

Provided front line supervision across multiple production lines and selected as the inaugural

3rd shift supervisor when the company went to 24 hour operations.

Authored and approved over 55 job training guides as training engineer.

VanDenBergh Foods/Unilever, Chaska, MN 1994 - 1998

Production Supervisor/Safety Coordinator

Observed machine operations to ensure quality and conformity of products to meet

specifications.

Supervised a team of 12 manufacturing and 14 packaging operators.

Responsible for production planning, productive utilization, yields, loss control, quality

assurance, documentation of all finished goods .

Entry of all daily production into MRP II program.

Key Accomplishments

Responsible for facility’s safety program, ensured compliance with all OSHA required

programs.

Member of GMP Committee.

VanDenBergh Foods/Unilever, Dalton GA 1993 - 1994

Production Supervisor/Management Training Program

Operated PCIM computer controlled system

Responsible for all aspects of production including scheduling, productive utilization, loss control, quality assurance.

Managed the entire sanitation program and received an “Excellent” rating from AIB

Entry of all daily production into MRP II program.

Key Accomplishments

Responsible for facility’s safety program, ensured compliance with all OSHA required programs.

Member of GMP Committee.

VanDenBergh Foods/Unilever, Chaska MN 1990 - 1993

Production Supervisor

Responsible for package integrity and quality assurance

Coordinated and executed start-up of inaugural third shift production team

Supervised and trained all sanitation, production, QC and maintenance personnel

Key Accomplishments

Received an “Excellent” rating from AIB on sanitation program

Member of GMP Committee, TRAINING AND CERTIFICATIONS

• EDUCATION

Basic Safety School, OSHA Voluntary Compliance Program American Institute of Baking, 1996

First Responder, Minnesota Emergency Medical Services Regulatory Board, 2005-present

Hazardous Waste Operations and Emergency Response Technician Certification,2009-present

5S Certification, Enterprise Minnesota, Minneapolis, MN, 2009

Lean Enterprise Workshop Series, APICS - The Association for Operations Management, 2009

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