Sterile Area Operator

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 & comply with all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA.

Skills

Abilities

Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

Able to prioritize work & multi-task

Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.

Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Attendance / Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant / warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Required to reach with hands and arms and frequently required to use hands to finger, handle or feel

Occasionally lift and / or move up to 50 pounds

Specific vision abilities required by this job include close vision

Frequently exposed to moving mechanical parts

Frequently exposed to toxic or caustic chemicals

The noise level is moderate

Work environment is a production / manufacturing environment

Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5; must maintain access.

EEO Statement :

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.