Media Tech-3rd Shift

POSITION SUMMARY

The primary purpose of this position is to prepare Vitek susceptibility and identification media and / or sub components, assembly and cleaning of dispense heads, dispensing system setup / verifications, ensuring timely delivery of high quality product to Card production, prepare Clean-In-Place solutions, 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.

PRIMARY DUTIES

1.    Perform all work in the Production Department in a safe manner in accordance with the company policy and / or procedure.

2.    Perform and document all manufacturing steps and verification as described in company procedures\policies for the following, but not limited to :

a.   Ensure Media and / or sub component preparation is completed in a timely manner for prompt product delivery to pour station based on production schedule.

b.    Filtrations – including checks to ensure that correct filters are used according to policy / procedure

c.    Verify that all media is appropriately labeled and stored based on all regulatory and Master Formulary specifications

d.    Proper Equipment (kettles, etc) operation and Clean-In-Place (CIP) operation

e.    Calibrations of instruments, scales and meters as needed

f.    Media dispense setup (setting the pump dispense volume, placing the dispense head and verifying connections and bag numbering to avoid switched wells)

3.    Assist with end of lot documentation review for Device History Record - Master Formulary, etc.  All documentation practices are to follow all appropriate procedures\policies. This includes but is not limited to the following :

a.    Process order checks for correct raw materials

b.    Accuracy and verification checks - Operator / Observer signatures, Manufacture and / or Hang time reports,

c.    Supporting documentation – weigh tapes, pH meter tapes, MES reports, well-remake reports, etc.,

4.    Report scheduling or availability issues with product planned for manufacture in MES to management or scheduler.

5.    Maintain a clean and orderly work environment by following the standards set forth in department 5S guidelines - before, during and after production runs.  This includes but not limited to :

a.    Cleaning and organizing lab workspace,

b.    Cleaning instrumentation / equipment,

c.    Sweeping and / or mopping floor as needed,

d.    Organizing and maintaining workstations according to 5s principles,

e.    Any unspecified actions required to maintain 5s compliance.

6.    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.

7.    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.

8.    Participate in the new product development and assist with new product transition to production from R&D and Industrialization as required.

9.    Reasonable, reliable attendance and punctuality is an essential job function required for this position.

10.    Performs other duties as requested by management.

KNOWLEDGE, EXPERIENCE & SKILLS

1.    Bachelor’s degree in a scientific field required. Biology / Chemistry preferred

2.    A minimum of one (1) year wet chemistry and / or bench work experience preferred.

3.    Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands. Excellent problem solving, time management and laboratory skills.

4.    Ability to work independently and in groups.

5.    Knowledge of sterile techniques and general laboratory procedures.

6.    Working knowledge of GLP / GMP and ISO guidelines.

7.    Strong PC skills (MS Office – Excel, Word, PowerPoint, Outlook; SAP desired).

WORKING CONDITIONS

Laboratory with exposure to chemicals

Physical Requirements

Work involves performing computer applications and standing for extended periods of time.

May be exposed to and require the handling of antibiotics and hazardous materials.

May be exposed to odors incurred during media production.

Lab work is performed wearing a hairnet, safety glasses and a lab coat.  Excellent personal hygiene required.

May be required to operate a forklift.

May be required to work extended and / or overtime hours.

Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Must be able to lift up to 50 pounds and push 150 pounds.

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