Manufacturing Assistant I/II, (Nights, 12hr, 7pm-7am)-2

JOB SUMMARY : The CMF Manufacturing Assistant position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non-routine cleanings and maintains gowning supplies for the locker rooms and gowning rooms at the CMF GMP facility to support continuous manufacturing operations. This position requires a shift schedule and gowning into a clean room environment. This position requires PPE. Must be able to document, record activities in electronic systems and comply with regulatory requirements, cGMP’s, Policy Documents and SOP’s. Must be able to maintain training at 95% or greater. Must always wear proper PPE and follow all safety guidelines outlined by the SOP and site policies when working in the facility. Must be able to perform general tasks as assigned by supervisor to support manufacturing, i.e staging materials, discarding waste, moving equipment, and other general clean room tasks.

JOB RESPONSIBILITIES :Responsibility Approximate % of Time Performs and Maintains Manufacturing facilities by routine/non-routine cleanings. (Daily, Weekly and Monthly Cleanings) 70% Handling and discarding of hazardous and nonhazardous waste. 10% Computer: Includes maintaining training and job-related functions. 10% Order and stock general supplies in the manufacturing production areas. 5% Perform other various task as assigned by the Supervisor/Manager 5% Total: 100%

MINIMUM REQUIREMENTS 3.1 Knowledge, Skills, Abilities 3.1.1 Assistant I: High school diploma or Associate degree with 0+ years of experience. Bio Works Certificate preferred. 3.1.2 Assistant II: High school diploma or Associate degree with 18+ Months of experience. Bio Works Certificate preferred. 3.2 Language Ability Ability to read and interpret English documents such as safety rules, standard operating procedures, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate with coworkers and supervisor. 3.3 Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. 3.4 Math Ability Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. 3.5 Physical Demands Must be able to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry cleaning supplies and waste as needed, but not to exceed the Essential Physical Functions of the job description. 3.6 Computer Skills Word, Excel, E-mail, ASCTrac and MODA. 3.7 Equipment Use Computer/Tablet, radio, Copy and Fax Machine

Work Hours: 12 Hour Shift / 7PM-7AM / 2-2-3

The job requires working 12-hour shifts which may include working overnight

WORKING CONDITIONS Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, workspace, etc.)? Yes No If yes, please explain: JOB DESCRIPTION T-0094 Rev 0 Job Description Template Due to non-routine cleanings and the manufacturing schedule, it is required, if necessary, to stay past the assigned shift to complete such request. This position requires standing for long period of times. For cleaning, this position also requires bending, kneeling, and reaching above head. Due to the use of Spor-Klenz, use of PAPR’s or respirators (full faced and half faced respirators) are required for the job description. Facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator. This position is considered “Essential Personnel” which requires 7 days a week work coverage even though the company closes, i.e. inclement weather. This position is required to ensure the cleaning is completed every day.

Essential Physical Functions Check physical demands that apply. Describe job responsibilities that require physical demands checked. 1. Strength a. Standing 80 % of time Cleaning Walking 65 % of time Cleaning Sitting 20 % of time Desk, Documenting b. Lifting 50 lbs. Cleaning Carrying 50 lbs. Cleaning Pushing 50 lbs. Cleaning Pulling 50 lbs. Cleaning 2. Climbing Platform in Buffer Prep Balancing 3. Stooping Cleaning Kneeling Cleaning Crouching Cleaning Crawling 4. Reaching Cleaning Handling Cleaning 5. Speaking All aspects of job responsibilities Hearing All aspects of job responsibilities, must be able to hear alarms. 6. Seeing All aspects of job responsibilities Depth Perception All aspects of job responsibilities Color Vision All aspects of job responsibilities NOTE 1: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work f