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2nd shift QA Auditor - Grand

Company: Akorn 2
Location: Decatur
Posted on: March 13, 2020

Job Description:

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.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Perform regular auditing activities, including monitoring of the following:
  • Compliance to acceptable aseptic practices
  • Adherence to Standard Operating Procedures (SOPs) and compliance cGMP for their respective areas
  • Conformance to appropriate good documentation practices, utilizing ALCOA+ principles
  • Review the production areas to ensure appropriate batch record and raw material issuance 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 Acceptance Quality Limit (AQL) testing on finished product
  • Involvement in decision making to stop production if quality standards are not being met.
  • Train hourly employees on proper technique and procedures.
  • Release finished product to transfer to other Akorn facilities
  • Review temperature chart recorders on a routine schedule
  • Audit the maintenance of a clean and sanitary environment.
  • Interact with other departments and may have interaction with outside customers.
  • Observe integrity testing of product filters
  • Review the Water forInjection (WFI) Hoot Loop System Alarm Messages routinely
  • Perform in-process Quality review of batch records
  • Review, approve and issue equipment to operations.
  • Perform line clearance including equipment, components and label verification.
  • Perform room releases for formulation/filling rooms for Outsourcing areas.
  • Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management.


    Qualifications
    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.

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


    EDUCATION AND EXPERIENCE
    • High school diploma or GED required.
    • One year of quality manufacturing experience preferred.
      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. Ability 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.
      • Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.
      • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
      • Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing.
      • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
        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.

        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 multiple projects and priorities in a concurrent manner.
        • Ability to work in an independent manner, as well as a group environment
        • Ability to apply deductive reasoning and analytical thought to understand complicated issues.
        • Ability to receive instructions and follow work rules and company policies.
        • Ability to follow safety and security practices.
        • Ability to meet deadlines and effectively deal with a high level of office stress.
        • Ability to maintain confidentiality of work assignments and personnel issues


          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.

Keywords: Akorn 2, Decatur , 2nd shift QA Auditor - Grand, Accounting, Auditing , Decatur, Illinois

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