Sterile Area Operator (Afternoons)

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

In accordance with written or oral instruction, cleans sterile and non-sterile areas. Operates auto scrubber, floor buffing machines, and carpet extractors. Mixes chemicals and operates fogging equipment.

Job Description

Cleaning

• Operates all equipment in the department for the purpose of cleaning and disinfecting/sanitizing/fogging aseptic and non-aseptic GMP areas

• Maintains supplies and work area in a clean and orderly fashion

• Receives supplies in area and moves to designated storage area

• Checks equipment and work area; notifies supervisor when repairs are needed

• Collects sterile and non-sterile garb. Separates, counts and moves to designated area. Stocks sterile and lint-free garb areas

• Maintains respirators, clean after use and store properly

• Disposes of trash and waste properly

• Flushes, cleans, and documents safety showers and eye washes. Reports any malfunction to supervisor

• Prepares sanitation solutions, such as acids, solvents, detergents, solvents, disinfectants, etc., used to perform cleaning of aseptic and non-aseptic areas

• Cleans and properly stores cleaning equipment

60%

Operational

• Operates washers, cappers and other equipment within the Sterile Filling Department.

• Packs-off product into trays and cases which may require lifting weights of up to 35 lbs.

• Evaluates finished product as required.

• Maintains a smooth flow of production and monitors equipment as assigned.

• Elevates any equipment or process deviations.

• Performs other duties as assigned by supervision.

• Maintains supplies and work area in a clean and orderly fashion.

• Maintains supplies in the controlled areas.

• Checks equipment and work area and notifies supervisor if repairs are needed.

• Cleans and properly stores waste containers for sterile filling production waste.

30%

Documentation

• Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work performed; updates room status

• Proactively communicates with area supervisor correcting documentation deficiencies and expediting the corrective process

10%

Compliance

• Performs all functions and ensure compliance with Standard Operating Procedures, Good Manufacturing Practices and Corporate Regulations

• Observes all safety and health regulations

Continuous

Other

• Operates equipment or performs duties as defined within the labor grade or lower labor grades within the LG9-LG10-LG11 upgrader path. Rotates on assignments to all positions within the upgrader path for ergonomic safety.

• Assists in training of new colleagues on job

• Maintains training requirements in assigned curricula

• Maintains eligibility to be Aseptic Core qualified and Media qualification.

Continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

• High School Diploma, GED or equivalent

• Successful completion of certified in-house qualification programs

• Willingness to continue on-going training as required by departmental objectives

• Must be aseptically area qualified; must maintain qualifications.  If qualification or requalification requirements are not maintained, an employee LG reduction or disqualification may occur.

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Basic understanding of manufacturing or packaging operations, as applicable

• Basic knowledge of industry practices and standards; able to apply basic principle, theories, and concepts

• Able to understand