Environmental Monitoring Specialist
Akorn 2

Job Info

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SUMMARY:
The Environmental Monitoring Specialist will perform all tests required to monitor the manufacturing controlled areas at Akorn’s Grand Avenue facility. In addition, they will provide support for efforts designed to evaluate the effectiveness of environmental monitoring controls used in the manufacture of sterile pharmaceuticals. This individual will work well with minimal supervision and report directly to the Environmental Monitoring Supervisor.

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.

• Leads development of Environmental Monitoring program qualification through development of risk assessments, protocols, and reports for existing and potential future sample locations and frequencies.
• Identifies opportunities for continuous improvement and drives changes aimed at enhancing the environmental monitoring program.
• Authors quarterly and annual environmental monitoring summary reports.
• Reviews personnel monitoring data, identifying trends that require corrective action.
• Organizes the review of all environmental documentation.
• Acts as a hands-on, active leader within the Environmental Technician group and provides knowledge to personnel.
• Must be able to demonstrate and apply good aseptic technique and cleanroom behavior.
• Must be able to demonstrate and apply good gowning technique during certification, re-certification, and routine monitoring.
• Counsels and trains personnel in gowning practices, aseptic technique and proper cleanroom behavior.
• Must be able to understand the operation and application of all monitoring devices that are automated or manual operation in the department.

• Must be able to demonstrate the ability to monitor and document all environmental parameters, such as viable sampling, personnel sampling, temperatures, humidity, and differential pressures under static and dynamic conditions.

• Update sample information in laboratory databases.
• Particle Measuring System review and interface.
• Validation protocol testing for new areas and facilities.
• Ability to assist in performance of thorough investigations related to Environmental Monitoring
• Must be computer literate, with experience in spreadsheet and database applications.

Qualifications
EDUCATION AND EXPERIENCE:

• Bachelor's degree in Biological Sciences preferred. Associate's degree with applicable aseptic manufacturing or microbiology experience and/or 5 years previous experience working in a clean room environment may be considered.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
• Must be able to pass gown and glove qualification and requalification.
• Must be available to float between 2nd and 3rd shifts, supporting PTO coverage as necessary.

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.

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