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The Fill/Finish Operator will be responsible for filling serials of antigen. Shall have an adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling. Must be able to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques.
High school diploma or equivalent
Good verbal and written communication skills and ability to train others.
Perform calculations and conversions involving weights, volumes, and percentages.
Ability to demonstrate problem solving and critical thinking
Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
Demonstrated understanding of systems, equipment, and processes
Ability to setup Fillers and trouble shoot mechanical issues
Experience with Windows Operating System.
Ability to work within several different computer systems and platforms. Computer aptitude that allows the person to adapt to future platforms and software.
Comprehension and application
Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
Duties & Essential Job Description:
Manufacturing and compounding sterile solutions and other parenteral classed products.
Obtaining, weighing, measuring and adding all raw materials as instructed on production procedures.
Set-up, operate and dismantle for cleaning, all equipment involved in the production process.
Accurately verify and document identity of all components used in formulation.
Responsible for assembling antigens into final product formulations and preparation of adjuvants or other intermediates.
Perform inspection and assessment of equipment and material condition prior to use. Determine when repair is necessary and follow up with appropriate documentation.
Sustained heavy lifting over extended periods of time.
Document operations with strict adherence to cGMP documentation practices.
Instruct workers of the lower grades as needed.
Be able to comprehend and follow Standard Operating Procedures/Filling Manufacturing Directions.
Fill biologicals according to cGMP’s, SOP, and Filling Manufacturing Directions.
Follow Standard Operating Procedures for the handling of hazardous wastes.
Recognize documentation deficiencies and bring the deficiencies and required corrections to the supervisors and technicians.
May be subject to DEA background check.
Other Duties as Assigned
Additional Education and/or Equivalent Experience
Successful completion of National Career Readiness Work Keys assessment
Knowledge of Hazardous Waste Handling
Knowledge of Decontamination and Sterilization
Knowledge of Traffic Patterns
Knowledge of or evidence of working with BPE methods
Understanding of Basic GMP/Documentation practices
Demonstrated ability and understanding of Safe working habits
Understanding of Basic Laboratory Practices, Measurements, Biology and Microbiology
Understanding of operating in an aseptic environment
Ability to work in a team environment
Other Functions & Responsibilities:
Assist higher Grade operators under supervision
May perform jobs of the lower grades as required
All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
This position description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the role.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status