Jason E. Needham

**** ***** **** **.

Rockford, IL 61109

Phone: 815-***-****

acxh9v@r.postjobfree.com

SUMMARY

** ***** ** *** ************** industry obtaining different positions to gain the knowledge, skills, and leadership experience needed to continue successfully in a management position. Vast understanding of Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) regulations, and Occupational Safety and Health Association (OSHA) regulations.

PROFESSIONAL EXPERIENCE

CATALENT (formerly CARDINAL HEALTH), Woodstock, IL Aug. 2002 - Present

Aseptic Supervisor

Schedule and implement Aseptic Maintenance and Aseptic Production activities including daily assignments.

Create Maintenance work orders and set ups for change of production using JD Edwards.

Communicate daily status reports for Aseptic and Maintenance work.

Production Supervisor

Delegate responsibilities to interview, hire, motivate and train/develop staff of 80+ employees involved in the BFS aseptic fill of liquid drugs and packaging.

Lead while conducting technical reviews, investigating deviations and implementing CAPAs; subsequently providing manufacturing input into integration and validation of new equipment/processes including serialization.

Create and revise Standard Operating Procedures.

Coordinate pilot program for deviation excellence management.

Proficient in leading the group through change management with an emphasis on process efficiency improvement while providing a quality product in a safe, cGMP compliant environment.

Conduct semi-annual and annual performance reviews for all direct reports, monitor progress, and assist in setting performance objectives and development plans.

Ensure strict accordance with the Batch Records and relevant Standard Operating Procedures (SOPs) and communicate documentation issue discrepancies and material delays to the Operations Manager.

Noted for dedication and involvement to safety management; monitoring facilities and processes for adherence to OSHA guidelines and EHS policies/procedures.

Manage associate attendance including daily monitoring of time keeping system and actively managing associate PTO balances.

Follow and enforce appropriate protocols for managing contingent workforce through third party staffing agencies.

Perform weekly audits of the environment for environment for potential safety hazards to ensure safe work environment as part of Safety Committee.

Evaluate/resolve conflicts of company policies and cGMPs.

Communicate daily with managers/supervisors of other departments to provide production updates.

Technical Lead

Responsible for scheduling, production, safety, quality and timely execution of all products manufactured on respective shift.

Conducted daily debriefings with other lead technicians on opposite shifts.

Responsible for and understands all technical aspects of both aseptic and terminally sterilized processes.

Developed experience in troubleshooting large manufacturing equipment and (WFI) water systems involved in the production of liquid pharmaceuticals.

Manufacturing Technician

Gained vast understanding and experience with batch formulation and aseptic liquid processing technology through Blow/Fill/Seal (BFS) machinery.

Trained new employees with respect to operating equipment and following all applicable SOPs as well as the safety guidelines of a pharmaceutical/manufacturing facility.

Completed and maintained documentation for pharmaceuticals involving complex multi-step manufacturing formulas and processes.

ROCK VALLEY COLLEGE, Rockford, IL Jun. 1999 – Aug. 2002

Grounds Keeper

Supervised and trained 18-20 employees to ensure work was completed and performed accurately regarding the up keep of the college campus.

Operated and serviced a variety of machinery including: tractors, skid steers, end loaders, etc.

EDUCATION

Bachelor of Science in Operation and Information Management May 2007

Northern Illinois University, DeKalb, Illinois

COMPUTER SKILLS

Microsoft Word PowerPoint

Excel Visual Studio

RELEVANT COURSEWORK

International Business Study Quality Management

Supply Chain Management Operations Analysis

Operations and Information Management Strategic Management

Business Systems Development Supply Chain Systems

AWARDS/ACTIVITIES/CAUSES

Bank of America Chicago Marathon

St. Jude Nashville Country Music Half Marathon

Chairman’s Award Recipient at Cardinal Health in 2003, 2005

Volunteer Fire Fighter 1995 to 2001

SnoCross Racing

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