Position Summary & Responsibilities:
Normal working hours are Sunday-Thursday from 10:00PM - 06:30AM.
The primary purpose of this position is the timely preparation, delivery, and set-up of quality, complex chemical media to Card Production., being current on training including curriculum procedures, work station organization and cleaning, establishing a safe work environment, housekeeping and maintenance functions in the production department.
- Perform all work in the Production Department in a safe manner in accordance with the company policy and/or procedure
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Perform and document complex manufacturing steps and verification as described in company procedures\policies for the following, but not limited to:
- Ensure Media and/or sub component preparation is completed with a high level of accuracy in a timely manner for prompt product delivery based on production schedule.
- Filtrations – including checks to ensure that all filters are functioning properly and per procedure
- Verify that all media is appropriately labeled, manufactured, and stored based on all regulatory and Master Formulary specifications
- Proper Equipment (steam kettles, etc) operation and Clean-In-Place (CIP) operation
- Media dispense setup with a high level of speed and accuracy (setting the pump dispense volume, placing the dispense head and verifying connections and bag numbering)
- Assist with end of lot documentation review for Device History Record - Master Formulary, etc. All documentation practices are to follow all appropriate procedures\policies.
- Report scheduling or availability issues with product planned for manufacture in MES to management or scheduler. Remain flexible in to abrupt changes in day to day do to unplanned changes
- Inspect and ensure all equipment is calibrated and in working order before performing any manufacturing task. management of any items found in need of repair immediately to prevent production delays. Perform start up and shut down procedures for the Lab equipment as described in company procedures\policies.
- Maintain adequate inventories of general lab supplies and inform department’s designated purchasing resource when additional items are required. Maintain FEFO for all long-term stocks, broths and chemical components.
- Participate in the new product development and assist with new product transition to production from R&D and Industrialization as required.
- Reasonable, reliable attendance and punctuality is an essential job function required for this position.
- Performs other duties as requested by management.
Education, Skills, & Experience:
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Bachelor’s degree in a scientific field required. Biology/Chemistry preferred OR
- Associates Degree with 2+ years wet chemistry and/or bench work OR
- High School Diploma/GED and 4+ years of wet chemistry and or bench work experience.
- A minimum of one (1) year wet chemistry and/or bench work experience preferred.
- Ability to work effectively and efficiently toward goal completion while maintaining a high level of accuracy and awareness in a complex, diverse environment with multiple and changing demands.
- Excellent problem solving, time management and laboratory skills.
- Ability to work independently and in groups.
- Knowledge of sterile techniques and general laboratory procedures.
- Working knowledge of GLP/GMP and ISO guidelines.
- Strong PC skills (MS Office – Excel, Word, PowerPoint, Outlook; SAP desired).
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