2nd Shift QA Auditor
Akorn 2

Job Info

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The 2nd shift QA Auditor is responsible for preventing or eliminating defects in our pharmaceutical products. This is a crucial role which requires working in a compliant manner in a high stress environment where adherence to details and deadlines is critical. The individual must display exemplary level of integrity at all times.

• Perform regular auditing activities monitoring compliance to acceptable aseptic practices.
• Adherence to SOPs and compliance cGMP.
• Conformance to appropriate good documentation practices.
• Check the production lines to make sure the right product is issued to match the batch record.
• Monitor the production process 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.
• Train employees on proper technique and procedures.
• Release finished product.
• 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.

Qualifications

• High school diploma or GED required.
• Previous manufacturing experience preferred.
• Knowledge of GMP preferred.

Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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