The Chemist II perform the testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations which require chemical analysis.
- Physical and chemical testing of, raw materials, bulk, pre-fill, finished and stability products.
- Maintaining stability sample data sheet.
- Ensure all testing performed is properly documented in laboratory notebooks
- Performing peer review of work and documentation of other analysts work.
- Maintaining the work area in an orderly manner.
- Keeps current with all SOPâ€™s required to perform their job assignments.
- Reports any problems with assays or components to the QC Lab Supervisor.
- Responsible for preparing and standardizing any reagents or standard materials required for analysis.
- Reports any supply needs to the QC Lab Supervisor and lab coordinator.
- Disposes of unused samples and laboratory waste in appropriate containers.
- Performs calibration and verification of lab instruments as applicable.
- Revise SOPs, initiate and write change controls, method verification protocol and reports.
- Performs Analytical Method Verification and Transfer as required.
- Performs equipment troubleshooting and supports laboratory investigations.
- Maintain QC laboratory and equipment in good working order.
- Assign and monitor Lab Technician and Chemist I job assignments as required. Train and mentor Lab Technician and Chemist I as required.
Company Overview Who we are?
- BA or BS in chemistry with five years of experience in a lab performing chemistry related duties.
- Experience with High Pressure Liquid Chromatography, Infra-Red (IR), Gas Chromatograph (GC), Ultra Violet/Visible, Particle Size Analysis, KF Titration and wet chemistry skills is required. Familiarity with HPLC/GC analytical software.
- Familiarity with GLP/GMP guidelines.
- Good Communication and writing skills.
- Familiarity with out-of-specification (OOS) and out â€" of â€"trend (OOT) investigations
- Write OOS and OOT reports
- Computer literate.
- Experience with USP/EP monographs.
- Must be detail oriented.
- Flexibility and adaptability in an ever-changing, fast paced environment is essentia
- Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
- Must have a team work attitude.
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 patientsâ€™ 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
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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