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Job Details
Novartis
Pharma Operator Assistant (3rd Shift)
Job Description
With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry
Job Purpose
Assist in the compounding and mixing of Pharmaceutical bulk product. Perform other required departmental duties as required, i.e. cleaning, sanitization, etc.
Major Accountabilities:
• Following set Manufacturing Instructions, SOP’s and GMP’s, assists compounders in tending mixing tanks, compounding kettles, various mills and mixers, pumps etc. that mix, compound and mill raw materials used in the manufacture of pharmaceutical products.
• Transfer raw materials from staging areas or compounding areas. Transfers bulk product from compounding to storage areas.
• Assists in weighing out specified types and quantities of liquid or solid raw ingredients via au-tomated dispensing systems or manual scales, according to formula.
• Transfers completed batches via pump or gravity drop into proper containers for movement to storage or other production departments.
• Proactively questions anomalies and utilizes opportunity for additional understanding of prob-lem resolution.
• Extracts bulk samples for laboratory analysis. May assist in the handling, dispensing and sampling of hazardous raw materials.
• Assists in the daily cleaning/sanitization of kettles, mixers, pumps, utensils and compounding rooms.
• Performs daily environmental monitoring according to schedule and SOP.
• May assist in the weighing/mixing of sanitizing agents.
• Completes required batch documentation records.
• Assembles and disassembles pumps, mills, kettles, etc.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regu-latory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flamma-ble, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour in-cident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
To perform this job successfully, an individual must have satisfactory visual acuity and peripheral vi-sion. Visual acuity and peripheral vision screenings may be used to screen applicants.
• Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.
• Satisfactory peripheral vision means a horizontal field of vision of at least 70° in horizontal meridian in each eye.
Job Purpose
Assist in the compounding and mixing of Pharmaceutical bulk product. Perform other required departmental duties as required, i.e. cleaning, sanitization, etc.
Major Accountabilities:
• Following set Manufacturing Instructions, SOP’s and GMP’s, assists compounders in tending mixing tanks, compounding kettles, various mills and mixers, pumps etc. that mix, compound and mill raw materials used in the manufacture of pharmaceutical products.
• Transfer raw materials from staging areas or compounding areas. Transfers bulk product from compounding to storage areas.
• Assists in weighing out specified types and quantities of liquid or solid raw ingredients via au-tomated dispensing systems or manual scales, according to formula.
• Transfers completed batches via pump or gravity drop into proper containers for movement to storage or other production departments.
• Proactively questions anomalies and utilizes opportunity for additional understanding of prob-lem resolution.
• Extracts bulk samples for laboratory analysis. May assist in the handling, dispensing and sampling of hazardous raw materials.
• Assists in the daily cleaning/sanitization of kettles, mixers, pumps, utensils and compounding rooms.
• Performs daily environmental monitoring according to schedule and SOP.
• May assist in the weighing/mixing of sanitizing agents.
• Completes required batch documentation records.
• Assembles and disassembles pumps, mills, kettles, etc.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regu-latory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Note: This position may require the labeling, packaging or movement of hazardous (flamma-ble, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour in-cident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.
To perform this job successfully, an individual must have satisfactory visual acuity and peripheral vi-sion. Visual acuity and peripheral vision screenings may be used to screen applicants.
• Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected.
• Satisfactory peripheral vision means a horizontal field of vision of at least 70° in horizontal meridian in each eye.