Akorn 2 QA Technician - 526BR in Decatur, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/ada/r/jobs/5153118

SUMMARY

The QA Auditor I performs quality assurance duties at the assigned facility to prevent or eliminate defects in products for sterile filling operation or in final inspection and packaging operations. This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times. The QA Auditor reports directly to the QA Supervisor or Manager of Quality Operations.

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ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Check the production lines to make sure the right product is issued to match batch record.

• Monitor the production processes and ensure consistency of procedures.

• Review/approve raw materials or components for use in production

• Check incoming components for conformance to specifications.

• Perform visual inspection of finished product.

• Perform verification of machine setting for inspection line

• Perform AQL testing on finished product

• Review data from environmental monitoring of controlled areas.

• Involvement in decision making to stop production if quality standards are not being met.

• May train hourly employees on proper technique and procedures.

• Release finished product to transfer to other Akorn facilities

• Review and change temperature chart recorders on a routine schedule

• Review batch record documentation for completeness.

• Audit the maintenance of a clean and sanitary environment.

• Interact with other departments and may have interaction with outside customers.

• Review daily/weekly/monthly and bi-monthly logbook entries for completeness

• Observe integrity testing of product filters

• Review the WFI Hoot Loop System Alarm Messages routinely

• Approve issued product identification cards for use in filling.

• Perform first Quality review of executed batch records at the completion of all processes.

• Perform verification of machine setting for inspection line

• Perform AQL testing on finished product

• Review, approve and issue green release stickers to operations.

• Performs inspection of retained units on an annual or as needed basis.

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QUALIFICATIONS

To perform this job successfully, an individual must be detail-oriented and possess the ability to multi-task and work on multiple projects simultaneously. An individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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SAFETY REQUIREMENTS

Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility

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EDUCATION AND EXPERIENCE

* Associate's Degree or equivalent from 2-year college or technical school*

* One year of quality manufacturing experience in cGMP environment and/or training

* *Or equivalent combination of education and experiences.

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JOB PREREQUISITES

* All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.

* Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopea, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's.

* Have general math skills; adding, subtracting, multiplication, division and percentage calculation. Abilit to calculate figures and amounts such as discounts, interest, commissions, and proportions.

* Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications.

* Strong verbal and written communication skills. Resourceful and well organized.

o Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.

* Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

PHYSICAL DEMANDS/ MENTAL DEMANDS AND WORK ENVIRONMENT

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. May require the ability to lift up to 50 pounds. Specific vision abilities required by this job include close vision for written work, PC use and evaluation of test specimens.

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Mental Requirements include:

* Ability to write, read and apply technical scientific writing, procedures and quality policies

* Ability to work independently in an efficient and detail-oriented manner.

* Ability to work on