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Akorn 2 2nd shift QA Auditor - 1588BR in Decatur, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/ada/r/jobs/6854544 SUMMARYn

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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A Quality Assurance (QA) Auditor I is responsible for performing audits of GMP records and reports (including: associated logbooks, forms, and batch records), and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

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nESSENTIAL DUTIES AND RESPONSIBILITIES:n

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+ Perform regular auditing activities, including monitoring of the following:

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+ Compliance to acceptable aseptic practices

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+ Adherence to Standard Operating Procedures (SOPs) and compliance cGMP for their respective areas

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+ Conformance to appropriate good documentation practices, utilizing ALCOA+ principles

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+ Review the production areas to ensure appropriate batch record and raw material issuance Monitor the production processes and ensure consistency of procedures

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

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+ nCheck incoming components for conformance to specifications.

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+ nPerform visual inspection of finished product.

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+ Perform verification of machine setting for inspection line

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+ Perform Acceptance Quality Limit (AQL) testing on finished product

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

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+ Train hourly employees on proper technique and procedures.

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+ Release finished product to transfer to other Akorn facilities

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+ Review temperature chart recorders on a routine schedule

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+ Audit the maintenance of a clean and sanitary environment.

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

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+ Observe integrity testing of product filters

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+ Review the Water forInjection (WFI) Hoot Loop System Alarm Messages routinely

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+ Perform in-process Quality review of batch records

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+ Review, approve and issue equipment to operations.

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+ Perform line clearance including equipment, components and label verification.

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+ Perform room releases for formulation/filling rooms for Outsourcing areas.

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+ Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management.


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nQualificationsn

QUALIFICATIONSn

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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nSAFETY REQUIREMENTSWear appropriate safety equipment: including Safety glasses, close-toed shoes and hearing protection, latex gloves are required in many areas within the facility.

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nEDUCATION AND EXPERIENCEn

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+ High school diploma or GED required.

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+ One year of quality manufacturing experience preferred.


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nJOB PREREQUISITESn

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+ All full-time mployees 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.

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+ 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.

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

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+ 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.

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

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

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+ The ability and willingness to change direction and focus to meet shifting organizational and business demands.

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+ Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs), reaching (waist to head), vision (20/20)

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