Granulation & Blending Operator II

Acrotech Biopharma inc.; South Brunswick (NJ); On-site; USD 39,000 - 44,000; Full time

Job summary

Aurolife seeks a Granulation & Blending Operator II to ensure that equipment such as Mechanical Sifter, Granulator, Fluid Bed Dryer, Fitz Mill, and blenders are clean and set up per Production Batch Record.

The role requires a High School Graduate with up to one year of pharmaceutical manufacturing experience; you will perform in-process checks, document results, and maintain equipment and clean rooms per SOPs, following cGMP procedures.

Qualifications

• Must follow written instructions precisely and perform basic math calculations.
• Should have an understanding/knowledge of cGMP, safety criteria or the ability to learn.

Responsibilities

• Clean and/or disassemble equipment after product runs per SOP.
• Set up equipment per SOP and Production Batch Record specifications.
• Maintain equipment in good working order and report wear or malfunctions to supervisor.
• Inspect equipment during runs to ensure safe, normal operation.
• Document setup, cleaning, and measurements in log books and Batch Records.
• Follow cGMPs and Standard Operating Procedures; perform other duties as assigned.

Skills

Follow written instructions

Basic math

cGMP knowledge

Education

High School Graduate

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced managementteam with expertise in manufacturing, R&D, Quality Assurance and Qualitycontrol and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

It is the Granulation & Blending Operator II’s responsibility to ensure that the equipment’s used for e.g. Mechanical Sifter, Granulator, Fluid Bed Dryer, Fitz Mill, and blenders are clean and set up properly. It is the operator’s responsibility to perform visual and physical checks of in-process and finished materials as per procedure of Production Batch Record.

Responsibilities

• Clean and/or disassemble the equipment e.g. Mechanical Sifter, Granulator, Fluid Bed Dryer, Fitz Mill, Blender after the completion of product run as per SOP.
• Clean manufacturing room after the completion of product run as per SOP.
• Set up equipment as per Sop’s, and as per specifications in Production Batch Record.
• Maintain equipment in good working order,inspect equipment for wear and tear, and have any worn or evaluate malfunctioning parts and report to Production Supervisor or Manager.
• Maintain equipment parts and supplies in proper condition.
• Make any machine adjustments necessary during the batch run as required.
• Document all set up and cleaning in the log book and other pertinent paperwork.
• Visually inspect equipment as it is running to verify the machine is running within normal and safe operation.
• Take in process measurements of during the product run, and document these measurements in Production Batch Record.
• Keep the equipment and room clean during the production.
• Make sure all paperwork is complete and accurate throughout and after production.
• Keep accurate records of equipment usage and inspections.
• Perform any and all additional tasks relating to the operation of the manufacturing department as requested.
• Follow company policies, cGMP’s and Standard Operating Procedures.
• Other misc. duties as assigned.

Qualifications – Skills & Requirements

• A demonstrated ability to follow written instructions precisely and perform basic math calculations is required.
• Should have an understanding/knowledge of cGMP, safety criteria or the ability to learn.

Education & Experience

• High School Graduate.
• Up to one (1) year of work experience in a pharmaceutical manufacturing environment.

Compensation

Min: USD $28.00/Hr.

Max: USD $32.00/Hr.

Physical Requirements

WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.