Manufacturing Assistant I​/II; Nights

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, e.g. staging materials, discarding waste, moving equipment, and other general clean room tasks.

• Performs and maintains manufacturing facilities by routine/non‑routine cleanings (Daily, Weekly, and Monthly) – 70%
• Handling and discarding of hazardous and nonhazardous waste – 10%
• Computer: maintains training and job‑related functions – 10%
• Order and stock general supplies in the manufacturing production areas – 5%
• Performs other various tasks as assigned by the Supervisor/Manager – 5%

Knowledge, Skills, Abilities

• Assistant I: High school diploma or Associate degree with 0+ years of experience. Bio Works Certificate preferred.
• Assistant II: High school diploma or Associate degree with 18+ months of experience. Bio Works Certificate preferred.

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.

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.

Math Ability

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.

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.

Computer Skills

• Word, Excel, E‑mail, ASCTrac and MODA.

Equipment Use

• Computer/Tablet, radio, Copy and Fax Machine.

12‑Hour Shift / 7 PM–7 AM / 2‑2‑3. The job requires working 12‑hour shifts which may include working overnight.

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 periods of time. 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.

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.

• Strength
  • Standing – 80% of time (Cleaning, Walking)
  • Lifting – 50 lbs. (Cleaning, Carrying)
  • Pushing – 50 lbs. (Cleaning)
  • Pulling – 50 lbs. (Cleaning)
• Climbing – Platform in Buffer Prep Balancing
• Stooping – Kneeling, Crouching, Crawling cleaning
• Reaching – Handling Cleaning
• Speaking – All aspects of job responsibilities
• Hearing – All aspects of job responsibilities, must be able to hear alarms
• Seeing – Depth Perception, Color Vision, All aspects of job responsibilities

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.