Investigation Specialist- Quality Control
Akorn 2

Job Info

---

The Investigations Specialist is responsible for investigating deviations that occur within the Akorn Somerset site utilizing investigation tools (5 why’s, fishbone, 6 M’s), to determine the true root cause. Also, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent a reoccurrence of the deviation. Perform a proper impact and risk assessment to evaluate product impact per FDA regulations. Write the investigation reports, verify the effectiveness of previously implemented CAPAs and track and trend deviations.

• Work with the cross function departments to perform a comprehensive investigation into deviations, out of specifications (OOS), and out of trends (OOT) per FDA regulations.
• Gather quantitative and qualitative data from various areas of operation for analysis of data for investigation.
• Conduct root cause analysis to determine the true root cause of all deviations.
• Perform product impact analysis and risk analysis for each deviation.
• Write deviation reports that are comprehensive, clear, concise, contain sufficient detail, and will withstand regulatory scrutiny.
• Ensure completeness and accuracy of all deviation reports.
• Ensure all investigations are completed in a timely manner to ensure closure of all deviations within 30 days from the date of initiation to comply with internal SOPs.
• Recommend quality process improvements to increase efficiencies and performance of the quality systems, operations, and personnel to prevent a deviation occurrences.
• Track and trend non-conformances and recommend additional actions, as required, to prevent re-occurrence of the deviation.

Qualifications

• Bachelor's degree required
• Minimum of 2 years' experience in a Quality role relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, and corrective and preventive actions (CAPA).
• Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
• Proficient with computer programs. TrackWise experience preferred.

Company Overview
Who are we?
Aside from being an industry leader with deep roots in the eye care industry, Akorn has proven through the years, to be a company of clear vision. Vision of what it takes to be a company that is continually developing and evolving in order sustain our mission, which is to improve the lives of those around us through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akon.com .
Why you should choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career of purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join us!!
What do we offer?

• Competitive pay
• Growth and development opportunities
• Tuition Reimbursement
• 3 weeks PTO + 2 Personal Days
• 9 company holidays
• 401 K match
• Medical, Dental and Vision Benefit Options (Active 1st of the following month following start date)
• 100% Paid Maternity Leave

• Fast paced, family oriented work environment
• Wellness Program
• Inclusive and diverse culture

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.

This job has expired.