Pharma Operator - Assistant

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 automated 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 problem 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 regulatory 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 (flammable, 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 incident 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 vision. 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.

Key Performance Indicators
• Manufacture according to Batch Right the First Time (BRFT) by supporting reduction in rejection of batches.
• Participate in Behavioral Based Safety Program (BBSP) by complying with all safety procedures and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures).
• Follow proper documentation procedures.

Impact on the organization: Critical, Limited Access Manufacturing Area

Ideal Background: Related Pharmaceutical experience with Chemical background

Education: High School Diploma or GED. Associates Degree preferred.

Experience: Minimum 1 year experience working with chemicals in cGMP environment
• Proficiency in a Dispensary environment, or equivalent
• Solid English reading/comprehension skills required to understand detailed SOP, formula and Manufacturing Instructions
• Basic mathematical skills. Working knowledge of Metric System.
• Ability to comprehend cGMP’s & SOP’s and identify compliance or non-compliance with same
• Ability to lift 50 lbs. and to wear and properly use a half or full-face respirator
• May be required to work in full body protective wear for sustained periods while handling Hazardous materials
• Ability to maintain a high level of physical activity.
• Compounding is a restricted area with a high emphasis on cleaning and sanitary practices.

The max pay rate is $23/hr for this postion