Coating Operator III

Coating Operator

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.

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 other duties as assigned.

Physical Work Activities and Exposure:

• Work is regularly performed inside in a manufacturing environment.
• Exposure to dust, odor, noise, and fumes.
• The noise level is usually moderate.
• Frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 75 pounds.
• Frequent sitting, talking, or hearing.
• Use hands to finger, handle, feel, or operate objects or controls.
• Walk short distances. Clean and/or disassemble equipments after the completion of coating process.

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 or GED Equivalent.
• 5+ years of work experience in a pharmaceutical manufacturing environment.

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…