Count me in! I am currently a Superintendent of Manufacturing for a pharmaceutical company, which makes sterile injectbales.
I have been working for this pharmaceutical company in NJ for 2 1/2 years.
In addition to experience I have a Bachelors of Science in Business and a Masters in Communication and Leadership from Seton Hall.
On the side, I am currently starting a online web based business. I have just completed my business plan.
Experience
Below is a overview of my experience
Nov of 00-02
Manufacturing Supervisor/ Solid Dosage Forms
Manager/Supervise for approximately 20-30 non-exempt and exempt Supervisors, Group Leaders, Tablet Production Operators and support staff of Solid Dosage Forms Manufacturing.
Responsibilities include production schedules, process, people, material, equipment, ensuring quality and regulatory standards as referenced in GMP’S, SOP’s, DEA, OSHA and Abbott standards.
Coordinates and plans daily work assignments, ensure process compliance, and maintain production schedule to meet demand requirements.
Responsible for employee training, performance, welfare, purchasing projects and equipment maintenance. Possesses effective people handling skills, motivates personnel and is responsible for communicating goals, job performance and training of direct staff.
Duties encompass production areas including Weighing, Granulation, Final Blend, Compression, Encapsulation, Film Coating and liquids.
Completes projects to improve production efficiency, upgrade/maintain equipment, improve the quality of the finished product, which includes change control.
Confirms accurate documentation for all process steps, initiates XDS electronic documents, including process deviation, NCMR’s, TSP forms, complaint investigation and change control reports.
Posses technical skill to make assessments of production aberrations.
Brings process to logical stop, recommends course of action to correct issues implements necessary steps to prevent future occurrences.
Responsible for the reconciliation and security of the controlled drug substance materials during processing and storage.
Maintains security and status for all Solid Dosage Forms and Packaging in-process security storage locations.
Provides all pertinent information by working with SAP to support financial inventory system and materials management. Insures accuracy with the movement of raw materials, finished goods and all in-process material documents.
Interacts with both internal and external vendors to accomplish established goals and projects.
Interacts routinely with QC, QA, PD, and technical Support to address/support production issues, investigations, deviations, and completes validation activity.
Writes, updates and approves revised departmental SOPs and ensures adequate training is conducted to maintain operator competency with respect to equipment and process.
Supports budgeting and capital planning by monitoring direct controllable cost, overtime, and supporting capital projects.
Experience
Oct of 1995-Nov 00
Supervisor/Team Leader/ Technical Operations
Provided supervision and leadership for approximately 10-15 non-exempt Tablet Production Operators, Group Leaders and support staff of Solid Dosage Forms Manufacturing
Perform all phases of manufacturing of Bayer products including, granulation, tablet coating, active suspensions, solutions, and final blend.
Posses strong analytical skills in proper operation of processing equipment, including: the Glatt Fluid Bed Dryer, Vector Hi-Coater, Lodige MGT Granulator, Azo Screener, Alexanderwerk RFG Sifter, and Quadro Comil.
Documentation, including: proper information recording for samples sent to Quality Assurance and Quality Control. In addition, equipment , batch information and Born On Manufacture Date (B.O.M.) are documented.
Product sampling in accordance with written procedures, including moisture testing for loss on drying (L.O.D.) to ensure our product is manageable for the compression phase.
Skilled in proper operation and maintenance of a variety of laboratory instruments and processing equipment.
Reconciliation of batch records to meet accuracy of FDA and Quality Assurance.
Advanced skills and understanding of laboratory analyses and technical processes.
Posses excellent oral and written communication skills in dealing with various levels of scientific/technical personnel.
Prepare and make recommendations to Department Manager.
Experince
Feb 94-Oct 95
Manufacturing Technician / Product Development
Team Leader Experience.
Assisting in trial runs during the compression phase and granulation phase.
Product Development processing equipment setup and breakdown.
Capsule inspection and weight checks for raw materials.
Raw material and finished product transfer.
Cleaning and sanitizing of processing equipment used for the granulation and the tablet coating process.
Inventory and stockroom control. Including material handling.
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