Qualification Summary: Highly qualified Senior Pharmaceutical Operator with 26 years of diversified Manufacturing experience 10 years working in a Aseptic environment. Highly responsible, mature, detailed and quality oriented individual. Focused plant operations leader committed to company core values, driving results and exceeding expectations.
Skills
cGMP, SOP, OSHA, ESH regulatory knowledge
Deadline-driven
Strong leader
Process improvements
MS Excel, Word and Outlook savvy.
Cross-training in Six Sigma Yellow Belt and Tier Boards.
Fork Lift Operator.
Cross trained in Warehouse Operations.
Work History
Machine Operator, 08/2013 - 11/2013 West Fraser – , ,
Verification of all raw materials against the Batch Record Responsible for pre-weighing and verifying weight raw materials for Blending, Granulation and Process Development departments.
Performed operation of the TOLEDO programmable weighing and label system.
Ordered raw material necessary from the warehouse, returned material.
Complied with cGMP, SOP, DEA and OSHA regulations.
Pre-weighed raw material in accordance with proper gowning and good documentation practices.
Operated a Servo lifter and Russell sieve.
Production Technician, 2013 - 08/2013 Kaiser Aluminum Corporation – , ,
Maintaining a position as a Production Technician adhering to cGMP's, SOP's, DEA and OSHA regulations.
Prepared equipment, cleared rooms, filled documents and logs, verified materials against documents, verified materials gross, net and tare.
Maintaining a position as a Production Technician strictly adhering to cGMP's, SOP's, DEA and OSHA regulations.
Operated a Freund Vector 60 Fluid Bed with a Wuster Insert from a Operator Display Monitor.
Operated an Agitator Filter Dryer Unit 60 and 1000.
Operation of a LOD.
Recorded process readings on Batch sheets.
Developed deep understanding of regulatory requirements concerning quality.
Maintained a position as an MRF Operator, running a Glatt Fluid Bed using a Wuster Insert operating it from a Operator Display Monitor Cleared rooms, Perform batch processing steps in accordance with manufacturing order instructions.
Document all required batch processing information batch records and logs.
Compounding and granulating of dispersion solutions.
Clean, set and tag equipment and verified for visual clean.
Operated High shear pump, high shear blender, oscillator, set up of curing ovens, drum lifter, large sifter, moved drums over 100kg and pallets up to 1000lb.
Maintain a position as Sr.
Pharmaceutical Operator
Following clean room class 100 SOPs and a
batch for batch execution.
Setup, operated and cleaned various types of equipment following a
validated cleaning sheet.
Trained in Aseptic Gowning Procedures.
Perform Set-up and operation of the 2 Cubic Foot Twin Shell
Blender.
Perform set-up, auto-tare, feed factor calibration, monitoring,
cleaning, and operation of the Micronizer and feeder unit.
Perform all start-up, shut-down and in-process monitoring, cleaning,
and operation of the Summit Filling Machine for the production of ASMANEX.
Perform the set-up and challenge of Fill Height, Gap and missing
Desiccant sensors on the Summit Filler Machine.
Perform Environmental Monitoring.
Perform sanitation and micro-biology monitoring.
Reacted to process alarms and adjusted chemical feed rates according to Batch record.
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