Technical Operations_Manufacturing Science & Technology (2nd shift)
55 Cantiague Road Hicksville NY USA 11801 Hicksville, NY 11801 US
- Assist in the compounding and mixing of Pharmaceutical bulk product. Perform other required departmental duties as required, i.e. cleaning, sanitization, etc.
- Following set Manufacturing Instructions, SOPs and GMPs, 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, cGMPs, 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.
- 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.
- 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 cGMPs & SOPs 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.
- 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.
- High School Diploma or GED. Associates Degree preferred.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.