Manager, QA Investigations
Akorn 2

Somerset, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


The Manager of QA Investigations/CAPA is responsible for the management of the Investigations, CAPA, and Customer Complaint Team, which includes ensuring timely closure of deviations, customer complaints, and CAPAs to achieve departmental and business goals. Performs approval of deviations, non-conformances, out-of-specification (OOS), Out of Trend (OOT), non-lab out-of specifications, corrective and preventative actions (CAPA), and product complaints. Responsible for tracking and trending quality issues and escalates any identified trends to Site Senior Management.

  • Responsible for the assignment, tracking, and monitoring of all deviations at the Somerset site.
  • Responsible for performing QA approval of all deviations, , out-of-specification (OOS), Out of Trend (OOT), non-lab out-of specifications, SCARS (Supplier Corrective Action Reports), corrective and preventative actions (CAPA), and product complaints within defined timeframes.
  • Responsible for providing guidance to the Investigators to ensure that all Somerset site investigations comply with regulatory requirements.
  • Work with cross-functional personnel to ensure that a comprehensive investigation is performed and effective corrective and preventive actions are created to prevent future occurrences of a deviation.
  • Responsible for coordinating priorities for the Investigators to ensure timely closure of non-conformances and customer complaints.
  • Responsible for creating department procedures to ensure compliance with current regulations and best practices.
  • Responsible for Tracking and Trending Quality Issues at the site and reporting any identified trends to Senior Site Management during weekly IRB Meetings and monthly QMR Meetings.
  • Responsible for compiling Investigations Metrics and presenting these metrics at the monthly QMR Meeting.
  • Responsible for hosting weekly IRB Meetings.
  • Provide Training to the Team on new systems and procedures.
  • Assist during regulatory inspections, customer audits and GQC Internal Audits as required.
  • Other duties may be assigned as required.



Qualifications
  • Bachelor’s degree in a Science Related Field and a minimum of 10 years’ experience in Quality Assurance, specifically, as the primary approver of deviations, non-conformances, out-of-specification (OOS), non-lab out-of specifications, corrective and preventative actions (CAPA), and product complaints.
  • Five years (5) of prior management experience is required.
  • Proficiency in TrackWise is a plus.
  • Prior experience working in an aseptic manufacturing environment is required.


Company Overview
Who we are?

Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients’ lives 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.Akorn.com .

Why 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 with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!

What do we offer?
  • Competitive pay
  • Growth and development opportunities
  • Tuition Reimbursement
  • 3 weeks PTO + Personal Days
  • 9 company holidays
  • 401K match
  • Medical, Dental and Vision Benefit Options
  • 100% Paid Maternity Leave
  • Fast paced, family-oriented work environment
  • Wellness Program
  • Inclusive and diverse culture
  • Adoption Assistance
  • Flexible Spending Accounts


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.

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