Coating Operator III

Aurobindo Pharma USA, Inc.•Dayton, NJ

6h•Onsite

About The Position

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has over 18 year's of history in extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control 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. It is the operator’s responsibility to ensure that the Coating Machine and Mixing Tank is clean and set up properly. Coating Operator has to ensure quality produced Coated Tablets by adhering to the Production Batch Records instruction.

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.
High School Graduate or GED Equivalent.
5+ years of work experience in a pharmaceutical manufacturing environment.

Responsibilities

Clean and/or disassemble Coating Machine and its parts, containers, mixers, room after the completion of coating operation as per SOP.
Clean Manufacturing Room after the completion of product run as per SOP.
Set up Coating Machine for run, including preparation of solution for coating operation as per Production Batch Record.
Maintain Coating Machine in good working order, inspect the machine for wear and tear, and have any worn or malfunctioning parts evaluated and reported to Production Supervisor or Manager.
Maintain tools and supplies in proper condition.
Make any machine adjustments necessary during the coating as required.
Document all set up and cleaning in the log book and other pertinent paperwork.
Visually inspect Coating machine and mixers as it is running to verify the machine is running within normal and safe operation.
Take in process physical measurements of tablets throughout the coating run. Document these measurements in Production Batch Record and make sure they are meeting the specification of Production Batch Record.
During coating process make minor adjustments as necessary to keep all physical characteristics of the tablet within specification as per Production batch Record instructions.
Keep the equipments clean during product run.
Make sure all paperwork is complete and accurate throughout and after coating process.
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.
Perform any and all additional tasks relating to the operation of the manufacturing department as requested.
Perform other duties as assigned.

Benefits

Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
Dental Benefits with three dental plan options through CIGNA
Vision Plan with two plan options through VSP
Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
Disability Insurance, Voluntary Short-Term Disability and State Disability
Long-Term Disability (LTD), State (short term) disability – where applicable
FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
HSA (Health Savings Account)
401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
Critical Illness and Accidental Insurance
Legal and Identity Theft Insurance
Paid Time Off - Paid vacation, PTO, Holiday