Statistician, Quality Engineering

Our Company
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, otics, 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.

Summary
Responsible for providing appropriate statistical assistance and training to all departments. This position also assists departments in study design and statistical analysis to meet the needs within the Akorn organization. This professional will be responsible to understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the Decatur manufacturing/packaging sites.

Essential Functions
The duties include providing a strong technical base with a vision of statistical analysis and trending. The following is not intended to be an all inclusive list of job activities, but rather a description of duties and/or functions that will be closely related to the job.

Create, analyze and interpret Annual Product Review reports for the site.

Analyze and interpret statistical data in order to identify significant differences in relationships among sources of information.

Evaluate the statistical methods and procedures used to obtain data in order to ensure validity, applicability, efficiency, and accuracy.

Plan data collection methods for specific projects, and determine the types and sizes of sample groups to be used.

Develop an understanding of fields to which statistical methods are to be applied in order to determine whether methods and results are appropriate.

Must be willing to work with regulatory agencies as required, including but not limited to the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Health and Safety Administration (OSHA).


Additional Responsibilities
Additional responsibilities may include assisting with Quality Engineering activities associated with equipment and/or processes. Access to transportation to attend various offsite meetings.

Qualifications
To perform this job successfully, 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.

Education and/or Experience
Bachelor's degree in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics. Minimum of 3 years related experience in a Pharmaceutical operation is preferred.

Job Prerequisites
Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Proficient in Microsoft Word, Excel, Project and in one or more major statistical software packages (e.g., SAS, R, MINITAB, and/or JMP).

Physical Demands, Mental Requirements and Work Environment
The position requires prolonged sitting. Requires eye-hand coordination and manual dexterity to operate keyboard, photocopier, telephone, calculator and other office equipment. Occasional high stress work requires dealing with customers/clients and regulatory agencies. May have exposure to hazardous chemicals.

Mental Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise
Ability to apply deductive reasoning and 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 office stress
Ability to accurately communicate ideas, facts and technical information
Maintain confidentiality of certain information


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