2nd shift QA Auditor - Grand
Company: Akorn 2
Posted on: March 13, 2020
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
- 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
- Check incoming components for conformance to
- Perform visual inspection of finished product.
- Perform verification of machine setting for inspection
- Perform Acceptance Quality Limit (AQL) testing on finished
- 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
- 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
- Observe integrity testing of product filters
- Review the Water forInjection (WFI) Hoot Loop System Alarm
- Perform in-process Quality review of batch records
- Review, approve and issue equipment to operations.
- Perform line clearance including equipment, components and
- Perform room releases for formulation/filling rooms for
- Communicate quality- related observations, issues, problems,
discrepancies and any violations of company policies or procedures
to the Supervisor/Management.
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
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.
- 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
- 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
- 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
- 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
- Ability to work on multiple projects and priorities in a
- Ability to work in an independent manner, as well as a group
- Ability to apply deductive reasoning and analytical thought to
understand complicated issues.
- Ability to receive instructions and follow work rules and
- 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
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.
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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