Group Leader, Quality Control- Finished Products
Akorn 2

Amityville, New York

Posted in Pharmaceuticals


This job has expired.

Job Info


The QC Group Lead will be responsible for analyzing and assisting in the scheduling of the QC laboratory sample testing following established procedures, stability protocols and protocols to conduct various independent and team driven laboratory experiments. The incumbent will assist with the day-to-day maintenance for an orderly QC laboratory such as safety, ordering and receipt of reagents, instrument calibration. The individual may assist with data auditing generated from the analytical testing of finished product and stability samples which includes, but not limited to:Chromatographic Techniques (HPLC, GC, TLC), Spectroscopic Techniques (UV-Vis, FTIR, AA), Titration Techniques (color-indicated and potentiometric), Dissolution, Viscosity, pH, and various wet chemistry/physical testing techniques. In addition, the Lead will assist in laboratory investigations as needed.

  • Analyzes samples of pharmaceutical finished products, in-process samples and others including research oriented samples.
  • Responsible for conducting investigations on aberrant results.
  • Participates in method transfer/validation studies and may serve as a team leader for a project or study.
  • Recommending changes to test methods or laboratory procedures to reduce variability and/or improve efficiency.
  • Audit other chemists’ lab notebooks for accuracy and adherence to approved procedures. Accurately document all activities, rigorously adhering to cGMP and all company standards.
  • Ability to interpret and follow USP/NF monograph and vendor method requirements.
  • Assists Laboratory Management with troubleshooting.
  • When instructed by Laboratory Management, train other Chemists on analytical procedures or instrumentation.
  • Develop, write, and revise all applicable controlled documents when necessary such as change controls, etc.,
  • Support management in releasing of finished product, stability samples, and raw materials if deemed necessary.
  • The support and promotion of the GMP Compliance Program (Akorn Standards of Ethics & Conduct) is an essential element of the performance standards and will be used in the overall performance ratings.
  • Take charge of the laboratory day to day operations in the absence of the Supervisor.


Qualifications
  • Minimum of Bachelor's degree or higher in chemistry or related field.
  • A minimum of 3 years of demonstrated excellence in the field of analytical chemistry.
  • Excellent computer and software skills.
  • Excellent problem solving aptitude, communication and multi-tasking skills.
  • Prior experience in a pharmaceutical (cGMP) laboratory setting is required.
  • Must be familiar with GC/HPLC chromatography, physical testing and the utilization of USP
  • Analyzes samples of pharmaceutical finished products, stability, in-process samples and others including research oriented samples.
  • Knowledge of laboratories regulatory programs and objectives (cGMP, GLP, etc.).
  • Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
  • Resourceful and well organized.
  • Advanced instrumentation skills, data processing and troubleshooting capabilities.
  • Excellent verbal and written communication skills with proven prior experience.
  • Must be able to work in a team environment.
  • Ability to train other chemists as needed.


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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