Manager, Quality Control
Akorn 2

Job Info

---

Manages, plans, coordinates, directs, and evaluates all activities associated with the Chemistry Laboratory. Ensures chemical testing is performed and in compliance with USP, FDA regulations, SOPs, ICH, ISO, and other regulatory requirements. Manage, direct, and mentor QC Chemistry staff.

• Drafts, reviews, updates and approves laboratory quality systems, validations, test methods, specifications, and SOPs.
• Manage Stability program according to FDA regulations, ICH, etc.
• Reviews and approves laboratory logbooks, notebooks, and documentation
• Oversees and/or purchases laboratory equipment and necessary supplies for the laboratory.
• Develop and revise as necessary, a Chemistry organization structure that is efficient and supports the business needs under management guidance.
• Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions. This includes succession planning.
• Ensuring completion of Analytical R&D method transfers into Quality Control laboratory.
• Reviewing QC documents that support analytical requirements in accordance with USP guidelines.
• Generating summary and trend analysis reports.
• Investigate OOS occurrences according to company procedures.
• Responsible for cGMP compliance and continuous quality improvement in the laboratory.

Qualifications

• Bachelor's degree (BS/BA) in Chemistry required.
• Minimum 7 years of experience in a pharmaceutical manufacturing Chemistry lab.
• Minimum 3 years of Supervisory/Managerial experience.
• Must have knowledge of current Good Manufacturing Practices specializing in sterile dosage forms, USP testing requirements for sterile product and Chemistry procedures, CFR, and other FDA regulations/guidelines.
• Must have a team work attitude.
• Will interact with all functional departments within the company including hourly, professional and management personnel.
• Must be detail oriented and exhibit strong interpersonal, organization, and communication skills
• Strong working knowledge of HPLC, GC and Spectroscopic analysis

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.