Safety, Compliance, Quality Assurance and Process Management

Mark S. Lewallen

Lincoln, Nebraska

Home Phone: 402-***-****

Cell 402-***-****

Email: *******@***.***

QUALIFICATIONS:

Well-developed leadership skills with successful record of setting and achieving

operational company goals

Analyze and interpret business periodicals, professional journals, technical procedures,

routinely present to all levels of Management

Maintain OSHA 30 hr. certificate for Industrial Safety

SQFI (Safe Quality Food Institute) Certified SQF Quality System Implementation

National Safety Council OSHA 30 hour Certificate

Nebraska Safety Council (NSC)Industrial Hygiene Certificate

NSC First Aid and CPR/AED Certificate

GCCC Operator 1 Certificate for Industrial Ammonia Refrigeration

HACCP (Hazard and Critical Control Point)Certified Program Practitioner

Key experience with; Quality Manual, Program and Procedure development, TQM, ISO

9001, corrective and preventive action system implementation, internal and external

auditing, HACCP, GMPs, GLPs, risk management, and document control

Experienced SQFI Certified Practitioner and Auditor, key in achieving and maintaining

Waverly Production Facility’s SQF Level 3 Certification, obtained 2011

Prepare and present weekly focus topic presentations to management teams, updating

current metrics, project development, and continuous improvement initiatives

Familiar with principals of 6 Sigma and capable of working with various root cause,

problem solving and continuous improvement implementations

Microsoft Office experience with advanced training in Access, Excel, Word, Power Point,

Project, and Outlook

EDUCATION:

Bachelor of Science, Nebraska Wesleyan University - Lincoln, Nebraska

Major: Biology (emphasis in Microbiology and Chemistry) May 1996

EXPERIENCE:

Tecumseh Poultry - Home of Smart Chicken: Tecumseh, NE and Waverly, NE (06/2009 to present)

Safety and Compliance Manager (1/2012 to present)

Ensure relevant company programs and policies are kept up to date with changes in regulation

(USDA, OSHA, SQF, EPA, IDALS, HFAC, Homeland Security) through the development and conduct

of routine internal audits

Assist Executive Management in key administrative initiatives

Direct Management and Supervisors in incident and injury investigations, trending and prevention

Manage compliance requirements including reporting and document control systems to ensure

proper controls, procedures and training support regulatory or permit requirements

Support Management and Supervisors in the development and application of program and

procedures key to their department functions

Engage with Management throughout project implementations to remove, change or add

equipment to either plant comply with program requirements for each functional need; Safety,

Quality and Operational process development, Procedure, Contractor or Vendor Approval,

Preventive Maintenance, Packaging, Labeling, Job Hazard Analysis and Training

Coordination of Safety Program requirements at two plants of key OSHA initiatives based on

regulatory developments; mock-audit coordination by qualified third parties

Manage Security staff in Waverly, contractor communications, approvals, training and compliance

Develop applications of key functions, analyze data trends, present to Executive Management

Administrative Manager of Process and Procedure Management System; electronic document

control for all contracts, programs, procedures, forms and label approvals for two plants

Process Development Controller (12/2011 to 1/2012)

Administration and validation of key operational metrics/results at both plants

Tracking of cross-departmental development meetings

Training and support of metrics with management to develop process improvements

Management of QMS, document control system and resource development

Process revision approval for all company procedures, policies, and programs

Conduct assigned department wide audits to establish optimized flow and apply corrections or

improvements to interdepartmental and cross-departmental functions

Auditing of programs, processes, procedures and manuals

Develop system based applications for audit process bringing about innovations to shorten path

from discovery to CPAV stages (correction, prevention, application and validation)

Establishment and enforcement of aggressive timeframes for audit response by management

Create and manage internal system CAPAT (corrective and preventive action tracker)

Ability to solve practical problems and deal with a variety of concrete variables in situations where

only limited standardization exists

Quality Assurance Supervisor / HACCP Coordinator ; Waverly, NE (11/2010 to 12/2011)

Quality Assurance Supervisor; Tecumseh, NE (01/2010 to 11/2010)

Managed Quality Assurance (QA) processes to ensure product safety and quality, conducted to

ensure compliance to USDA regulations

Established finished product specifications and maintained HACCP plan

Managed QA department budget with 4 to 11 associates including department and laboratory

supply ordering, staff scheduling, interviewing, hiring, coaching sessions, and evaluations

Conducted daily review and verification of compliance for Pre-Op, SSOP inspections, CCP records,

pre-ship activities, conduct daily random task monitoring

Audited and when applicable revised current Standard Operating Procedures, Hazard Analysis

Critical Control Point plans, and Sanitary Standard Operating Procedures related to QA Food

Defense and Food Safety Compliance

Management and USDA meetings weekly to review current or ongoing topics, present

production, quality, food safety, facility and safety metrics

Conducted weekly compliance and safety audits, reporting findings to facilitate corrections

Submitted continual performance improvement requests, and supported implementations

Managed product specification profiles, organic certification program, labeling and finished

product specifications

Organized and conduct ongoing training for departmental, new hire and company-wide needs, to

ensure currency with required company procedures, GMPs, regulations and quality policy

In Tecumseh served on the Facility Project Committee; Review large investment facility projects

assess project needs and timeline, analyze bid proposals for quality and ROI

In Waverly served on the Sanitation, Process Safety Management, Progress In Plant, Safety

committees as well as HACCP committee as site coordinator

Parts / Inventory Control Clerk; Tecumseh, NE (06/2009 to 01/2010)

Ordered parts, equipment, and supplies, reviewed work orders daily and tracked parts usage

Generated weekly usage and monthly inventory reports for Management and Accounting

Managed 440K of inventory consisting of 2000 items by conducting audits of the parts room ensuring

proper levels are maintained lateral maintenance

Qualia Clinical Services: Omaha, NE (11/2006 to 01/2009)

Director, Regulatory Affairs / QA (10/08 to 1/09)

Quality Assurance Manager (11/06 to 10/08)

Managed quality team personnel including interviewing, hiring, and terminations, and conducted

performance evaluations

Ensured studies conducted were performed according to GCP and ICH guidelines, applicable

regulations, company SOP, and study protocol requirements

Developed and revised relevant company wide and global Standard Operating Procedures,

Operational Training Plans, and source document templates

Managed initiation activities, maintenance and archiving of investigator regulatory files using

various data capture, and data record management systems

Coordinated submissions to the IRB of record for each study conducted

Streck: Omaha, NE (09/2000 to 11/2006)

Quality Assurance Coordinator

Served as Lead Auditor, administered Internal Quality Audit system, and vendor audits

Managed company wide Corrective and Preventive Action System for process and audit

noncompliance, performed statistical analysis; presented regularly to management

Conducted reviews and initiated revisions to QA controlled documents and Device Master Records

Served as resource for compliance, process mapping for root cause and solution implementation

Assured compliance of product manufacturing: identifying process and product specification

variance, assembled supporting data for file submissions, and validated 510(K) filings

Served on the Change Review Board, and Departmental Area Safety Committee

Served as Chairperson of Internal Audit and Quality Improvement Team

North Country Thermal-Guard: Lincoln, NE (03/1999 to 09/2000)

Sales Representative / Assistant Marketing Manager

MDS Harris: Lincoln, NE (11/1997 to 12/1998)

Clinical Study Manager - Clinical Research Division (06/98 to 12/98)

Extraction Analyst Level II - Bio-analytical Science Division (11/97 to 06/98)

Centeon Bio-Services: Lincoln, NE (08/1994 to 11/1997)

Screening Technician and Phlebotomist

Quality Assurance / Quality Control Supervisor

AFFILIATIONS:

Associate Member – ASQ (American Society for Quality)

Certified Practitioner and Auditor – SQFI (Safe Quality Food Institute)

Sky Knights Model Airplane Club, Lincoln, NE

Academy of Model Aeronautics

PADI Certified Open Water Scuba Diver

Volunteer, Lincoln Public Schools, Lincoln, NE and Muscular Dystrophy Association

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