Annual Product Review Specialist at Akorn 2 in Decatur, Illinois

Job Description:

SUMMARY:



The Annual Product Review (APR) Specialist is responsible for the creation, evaluation, and maintenance of Annual Product Reviews and product quality metrics data required by corporate standards, validation documents and FDA guidance. This position is instrumental in the identification of manufacturing process trends and the review of chemistry and microbiology data and escalates issues to senior site management. Other key accountabilities include coordination and compilation of key product metric information across departments to ensure Akorn is in conformance to FDA guidance. This position will interact with several departments including Manufacturing operations, Packaging operations, Engineering, Validation, Quality Control Laboratory, Microbiology Laboratory and Quality Assurance. This individual will be responsible to understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are ongoing at the Decatur manufacturing/packaging facilities.



ESSENTIAL FUNCTIONS:



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.

• Issues deadlines to other departments for the Annual Product Reviews.


• Ability to influence other department managers and personnel over whom you do not have no direct authority to collect data.


• Compiles, gathers and organizes product specific information for Annual Product reviews.


• Demonstrates technical knowledge to write and/or review detailed equipment / facility / system specifications in relation to process control systems and related technology.


• Creates APR reports and circulates for approval by all approving departments to support product lifecycle.


• Develop or update procedures, policies, or standards.


• Must have attention to details when compiling and reviewing data.


• Strong verbal and written communication skills to work across departments.

• Ability to plan and organize several work streams in parallel to meet deadlines.


• Must have the ability to read and understand Master Batch Records and/or other technical documents.


• Work independently while handling multiple projects with various timelines.


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


• Must understand instructions and react favorably in complex situations.


• Collate, file, scan and organize documentation.


• Serve as a scribe for customer and regulatory audits.

• Other duties as requested by manager.
  
  

Qualifications

MINIMUM 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.

• 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 and Microsoft Excel.
  
  
  
  EDUCATION AND EXPERIENCE:
  
  
  
  Bachelor's degree in the life sciences or related field preferred. Minimum of 3 years related experience in a pharmaceutical operation is preferred. Advanced technical writing skills, investigation skills and experience with statisticsis a plus.
  
  
  
  PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
  
  
  
  The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
  
  This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and 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

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. Apply Now