NOTICE: The following includes data on essential functions, as well as physical, mental, academic and experiential requirements for the job defined herein. This description is meant to serve interviewers, applicants, managers and incumbents as a reference tool for determining whether applicant or employee qualifications are sufficient to perform the tasks and assume the responsibilities as described. Some aspects of the job may change over time, according to business needs, which changes may not be recorded herein at this time.
SUMMARY: Reviews, coordinates, and assists to ensure non-conformance's are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined timeframes.
ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned.
Track all Non-Conformance/Deviation records to ensure the timely closure of all records. Follow up with the Assigned To's as needed for status and to ensure support is available to ensure completion by the due date.
Provide SME support on the use of the Akorn TrackWise workflows to end users as needed.
Provide guidance to Assigned To's of investigations on performing investigations and in the use of Root Cause Analysis Tools.
Provide guidance and training to other personnel/new hires in the Investigation/CAPA group.
Manage CAPAs to ensure timely closure of actions resulting from various types of investigations.
Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.
Act as the Investigation lead for minor Non-Conformance/Deviations investigations as needed.
Perform the closure of Effectiveness Checks.
Manage the Effective Checks to ensure they are completed by the required due date.
Perform Risk assessments, process FMEA analysis to support identifying the exact root cause and evaluate the risks.
Perform Trend investigations identified as part of regular investigations.
ADDITIONAL RESPONSIBILITIES:
Assist during regulatory inspections or other audits as required
Provide training to functional areas on compliance issues
Provide training on the use of TrackWise, on performing investigation, and performing root-cause analysis as needed.
Other duties as required
Qualifications EDUCATION AND EXPERIENCE:
Bachelor's degree and a minimum of 6 years' experience (preferably sterile products) in a Quality Systems relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints. In addition, experience in performing cGMP related training.
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.
Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
Proficient with computer programs. TrackWise experience preferred.
Six years of previous quality experience in pharmaceuticals or related field.
Preferred experience in sterile product manufacturing as it relates to QA functions such asnon-conformance's.
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.