Process Quality Assurance

GENE A. JONES

**** ****** ****** ~ West Chester,OH 03820

Phone: 317-***-**** ******@*****.***

QUALIFICATIONS

Talented Team Leader, Supervisor and team player with more than 20 years of experience supervising manufacturing/production processes in Pharmaceutical, Biotech and Food-Grade environments. Goal-oriented and people-centric, with a history of success in driving change/continuous improvement of both personnel teams and process efficiencies. Exceptional credentials.

• Skilled in assessing organizational strengths and developmental needs.

• Excellent written and verbal communications; effective with colleagues and subordinates of diverse technical and cultural backgrounds.

• Demonstrated success at meeting/exceeding production goals and streamlining processes in varied industries/manufacturing environments.

• Expertise in GMP/cGMP, OSHA/FDA compliance, Quality Systems Development, Lean Manufacturing/Taguchi Techniques, Strategic Process Improvements. Kaizen/Value Stream Leader. Manufacturing Safety Chairperson. Six Sigma Area Champion.

• Proficient in Windows (2000 and 95); Microsoft Word, Excel, PowerPoint; Lotus Notes; Trackwise; Minitab 14, LIMS, Delta V.

CAREER ACHIEVEMENTS

Decreased Downtime: Reduced clean-room turnaround time by 2 hours at Eli Lilly by applying Six Sigma principles. All departments now employ this format.

Personnel Development: Implemented “empowered team” activitities in each Supervisory role, enhancing group acceptance of/participation in new policies, procedural changes and higher production goals. Extensive involvement in developing and leading training programs in each Supervisory role.

Consistent and Reliable: Consistently met production goals/schedules and customer specs/deadlines. Achieved a stellar record of professional commitment, missing only 2 days of work in 18 years.

PROFESSIONAL EXPERIENCE

Amylin Pharmaceutical, Cincinnati, OH 2010-Present

Production Supervisor, Bulk (Compounding Supervisor)

• Provides leadership and coaching/mentoring relationships with direct reports

• Schedule manufacturing staff to ensure timeliness are met on a daily basis

• Communicate manufacturing process status manager and internal customers

• Ensure are all direct reports trainings are current and compliant to GMP criteria

• Deviations submitted within 24 hr of occurrence; in addition to writing and revising SOP’s and closing CAPA’s; participate in Kaizen events; conduct safety meetings

• Provide assistance in troubleshooting and manufacturing process issues

• Ensure all routine maintenance for equipment completed through SAP or Maximo

LONZA BIOLOGICS, Portsmouth, NH 2006-2010

Production Supervisor, Downstream Process

• Supervise departmental staff and operations (purification of product from Upstream Process group).

• Manage daily production schedules, materials/batch records; determine shift assignments/priorities.

• Oversee multi-departmental floor operations; provide troubleshooting/assistance as needed.

• Provide on-the-floor training to correct identified gaps in formalized technical and GMP training.

• Facilitate inter-departmental flow of work orders, dispensing, PMs and QC to optimize production.

Primary Projects:

• Lead the exercise of 5 S/6 S concepts on the manufacturing floor.

• Forecast and meet indirect materials budgets and overtime budgets.

CARDINAL HEALTH, Albuquerque, NM 2005-2006

Supervisor, Sterile Filling

• Supervised 25 non-union employees; managed hiring, scheduling, daily/annual performance.

• Developed departmental policies/procedures; trained staff to implement them successfully.

• Managed raw materials inventory: controlled and coordinated flow of raw materials and packaging.

• Evaluated engineering changes; formulated appropriate production response and procedures.

• Ensured all equipment/process lines adhered to SOPs and cGMPs.

Primary Projects:

• Restructured process/procedure to reduce clean room turnaround time by 2 hours.

• Helped to streamline manufacturing process for both oral and injectable drug production.

ELI LILLY & COMPANY, Indianapolis, IN 2001-2005

Team Lead, Aseptic Area

• Planned and scheduled production; coordinated and controlled flow of raw materials and packaging.

• Performed clean-room set-up of aseptic equipment for injectable products.

• Managed critical dose-control process in compliance with FDA regulations.

• Monitored/evaluated all aspects of manufacturing process; enforced adherence to quality standards.

Primary Projects:

• Established training system for new personnel entering clean-room environment.

• Developed training programs to prevent downtime, reduce set-up time and increase production. Restructured process to reduce clean room turnaround time by 3 hours.

• Participated in design of streamlined manufacturing process (SMED committee).

• Contributed to “Near Miss Program” to eliminate production safety issues (JSA Member).

NATIONAL STARCH & CHEMICAL, Indianapolis, IN 1994-2001

Process/Chemical Operator

• Operated food-grade process equipment; monitored/maintained precise ingredient tolerances.

• Trained staff in OSHA-required policies and procedures.

• Served as Union Steward; mediated operational issues between plant management/union members.

A.E. STALEY MANUFACTURING CO., Decatur, IL 1990-1993

Process Operator

• Operated corn-syrup process equipment; quality-tested density against final customer/plant specs.

• Operated I.S.O. to maintain pH and made process adjustments for lab analysis.

• Participated in Safety/Hazardous Committee planning for chemical spills/safety preparedness.

Water Treatment Operator

• Operated/maintained Laboratory and water treatment equipment; promoted to Process Operator.

EDUCATION, CERTIFICATIONS AND TRAINING

PURDUE UNIVERSITY, Indianapolis, IN

Bachelor of Science, Organizational Leadership and Supervision, Dean’s List; 2014, Expected

Associates Degree, Organizational Leadership and Supervision, 2008

Quality Assurance Certificate, 2005

Leadership Certificate, 2005

Six Sigma Green Belt, 2004. Currently pursuing Black Belt.

ISO 9002 Certified

ADDITIONAL CERTIFICATIONS / AFFILIATIONS

Certified in: Pharmaceutical Equipment, Aseptic, Hazardous Chemicals, Industrial Safety, Respirators, Forklift Trucks

Member: American Society of Quality

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