Quality Manager

John J. Roscovich

**** **** **** . ***********, ** 19320 . 484-***-****

abgx3k@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Manufacturing and Production Leader with extensive experience in the

pharmaceutical and chemical industries, capable of directing teams in the

achievement of manufacturing goals and programs.

Management & Staff Supervision Safety & Quality

Supply Chain Management Shipping & Receiving

Production Scheduling Regulatory Compliance

EXPERIENCE

LONZA, INC, Conshohocken, PA 1992 -

2010

Manufacturer of fine chemicals for pharmaceuticals

Warehouse Supervisor 2008 - 2010

Supervise Warehouse staff in the shipping, receiving and staging of all raw

materials and finished product.

. Monitor inventories for accuracy and sufficient production levels in

SAP.

. Responsible for maintaining a clean facility meeting cGMPs standards

ensuring all employees were sufficiently trained in working in a cGMP

facility.

. Met standards and regulations and ensured proper handling and

inventories of controlled substances.

. Partner with Production and QA in Customer and Agency Audits and

ensure Regulatory Compliance as required in GMP, DOT, IATA and IMDG

regulations.

. Ensure proper training and maintenance of certified forklift

operators.

o Accomplishments - physical reorganization of all material's in

inventory by grouping raw materials to flow with the production

schedule. Purchase and installation of racking for two warehouses

where no racking previously existed. Reduction in the cost of

international shipments through proper product investigation

regarding hazard classes of materials.

Operations Lead, Infrastructure 2007 - 2008

Focus on achieving production, quality, delivery and cost goals. Drive

process improvements through interfacing at all levels of the organization.

. Investigate and determine root cause of VOC (Volatile Organic Carbon)

shutdowns in Environmental.

. Coordinate and conduct the sanitization of the plant Purified Water

system.

. Monitor CD based training program and conduct training for operations

personnel as required by Production & Safety Managers.

. Site building and grounds management/upkeep.

o Accomplishments - Determined root causes of VOC shutdowns minimizing

impact on environment,

production schedule and EPA reporting. Reduced the time that Purified

Water Sanitization's were completed through coordination of the

Scheduling, Engineering and Production departments dropping the hours

from thirteen to seven. Reviewed and selected new site services

contractors with a lower cost and higher quality work.

Production Manager 2003 - 2007

Drive daily initiatives of safe work practices, consistent dedication to

the manufacture of an exceptional quality product, and strive for optimal

efficiency levels.

. Recruit, train, develop and supervise Production personnel, ensuring

safety and quality.

. Monitor production schedule to ensure on-time quality products for

shipment.

. Hands-on participation in audits conducted by FDA, DEA, OSHA, ISO and

other regulatory agencies.

. Partner with Quality Assurance, Quality Control & Analytical,

Materials handling and Maintenance on productivity improvements and

cost reduction programs to consistently improve product output and

quality.

. Respond to all investigations and work to resolve to customer

satisfaction.

o Accomplishments - Developed testing program to ensure that candidate

qualifications were initially met and that interview time was

maximized. Set-up Production Operation Teams as Subject Matter

Experts on a specific product. Implemented twelve hour work schedule

to enhance productivity while still ensuring the chemical operator

quality of life change was minimal.

John J. Roscovich - page 2

Production Scheduler/Planner 2000 - 2003

Maintain a production and shipping schedule that meets the needs of

customers and utilizes the facility capacity efficiently, distributing raw

materials on time to the site.

. Prepare and adjust yearly, monthly, weekly and daily production

schedule based on sales forecast.

. Allocate products to equipment based on current utilization of

equipment, batch size, cycle time and labor hours.

. Establish weekly and monthly targets related to production and

shipping schedules.

. Collaborate with Operations to ensure clean scheduling with regard to

Environmental, Maintenance and Quality scheduling.

SMITH KLINE BEECHAM, INC, Conshohocken, PA 1974 -

1999

Pharmaceutical Manufacturer

Production Manager 1992 - 2000

Manage the planning, scheduling and production activities of five

Operations Leads, four Supervisors and 20+ Chemical Operators.

. Ensure the efficient, safe and quality production of APIs in a cGMP

facility.

. Perform training for all aspects of Production.

. Develop manufacturing plans and measure team performance against

goals. Continually re-assign resources to meet the manufacturing

schedule on an ever-changing basis.

. Establish and maintain standards for safety, productivity, costs and

housekeeping.

. Write, implement and enforce SOPs.

. Review and audit manufacturing records and documentation (batch

records, etc.).

. Coordinate process and cleaning validation requirements for specific

products.

. Conduct performance evaluations for staff and coordinate safety

meetings for all of Production.

Production Shift Superintendent 1986 - 1992

Supervise the daily manufacturing operations across the department and plan

and manage the activities of 20+ Chemical Operators.

. Responsible for safe and efficient operation in the production of APIs

and intermediates for pharmaceuticals, supporting and enforcing safety

and environmental standards.

. Actively support and promote continuous improvement standards,

overseeing and helping to develop Chemical Operators on shift,

including annual performance evaluations.

. Maintain required process safety documentation and batch records and

manage fixed costs in area of responsibility.

. Ensure that all Company and Regulatory standards are met for

Production/Operations employees.

. Investigate and resolve performance and disciplinary issues including

suspensions and terminations.

. Responsible for training and Safety meetings for all subordinates.

Warehouse Supervisor 1984 - 1986

Manage physical inventory of raw materials and released finished goods on

schedule and within budget.

. Monitor, direct, coordinate and prioritize the activities of assigned

staff of 5 Warehouse Personnel, ensuring a productive and efficient

work environment where safety and cGMPs are maintained.

. Strong focus on employee and equipment training.

. Responsible for receipt of all raw materials & site supplies, picking

& staging of all raw materials for production and shipment of

intermediate & finish Goods both domestically & internationally.

Production Operator 1974 -1984

Responsible for operating charging, blending, material handling and

packaging equipment in a pharmaceutical process plant.

. Assemble, operate, troubleshoot, disassemble, and clean processing and

packaging equipment following appropriate SOP's and Work Instructions

for APIs, antibiotics and controlled substances.

. Execute batch records, maintaining strict adherence to cGMP's and site

SOP's.

UNITED STATES AIR FORCE 1970 -

1974_______________

. MOS - Security Police

. Viet Nam 1971-1972

TECHNOLOGY AND TRAINING

Microsoft Outlook, Excel, Word, PowerPoint, SAP, Time Management,

Successfully Managing People, Cost Accounting I, Essentials for Project

Management

REFERENCES

Available Upon Request

Contact this candidate