cGMP Production Associate
Akorn 2

Somerset, New Jersey

This job has expired.


  • Provide real time input to Production Supervisors and Team Leads on all documentation, i.e. time, temperatures and signatures, on forms, logbooks, MBRs within the formulation, filling and packaging departments.
  • Conduct walk-throughs for cGMP potential concerns; and subsequent reporting and tracking to closure.
  • Assist in CAPA closures
  • Perform logbook and BR reviews
  • Request all necessary controlled documents from QA Documentation
  • Trend and document errors and omissions
  • Direct operators on correct documentation per effective SOP’s
  • Assist in trainings such as aseptic behavior training in conjunction with Quality
  • Conducts cGMP training on all applicable materials approved by Quality
  • Work with Production Management to follow up on all related production findings from FDA, other regulatory bodies, contract customers, internal audits, etc
  • Review operator’s practices for proper aseptic techniques
  • Assist in JDE transactions


Qualifications
    • High School Diploma or GED
    • Minimum 3 years pharmaceutical experience
    • Experience in a cGMP environment
    • Experience in aseptic processing including formulation filling and packaging
    • Experience in aseptic gowning
    • Excellent oral and written communication skills


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 atwww.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.


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