Excipient Operator- 3rd shift

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Responsible for building, cleaning, and packaging of various Single-Use assemblies per Engineering Process Records (EPR), drawings, and Standard Operating Procedures (SOP).
Wear appropriate personal protective equipment (PPEs) and report all near miss and first aid events.
Responsible for following cleanroom protocols and cGMPs in order to maintain ISO Class 7 environment.
Be an activate participant in the continuous improvement process and follow appropriate change control procedures.
Escalate potential process and/or product deviations to prevent scrap, rework, and customer returns.
Daily organization (6S) and cleanliness of work area and common areas.
Assist with the inventory accuracy by properly returning unused parts and components to stock in sealed bags with part number and lot traceability.
Participate and work within ISO 9001:2015 quality standards guidelines in all manufacturing areas in accordance with company quality goals.
Meet internal manufacturing schedules which drive on-time delivery.
Complete and sign-off EPRs for each operation completed during the assembly.
Complete assemblies within the allotted time stated on the work order.
Instill a build it right the first time mentality.
Performs other duties as assigned.

QUALIFICATIONS (Education/Training, Experience and Certifications)

Minimum Qualifications:
High School completion or equivalent (GED)
0-2 years equivalent experience in production in a cleanroom environment

Preferred Qualifications:
Experience working in a cleanroom environment
Experience interpreting engineering drawings
Knowledge of Lean manufacturing

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Strong communication skills
Ability to work in a team environment
Perform duties with the highest regard for safety and quality
Ability to be trained on and adhere to all cleanroom protocols
Ability to understand and follow site protocols, policies and procedures
Must be flexible, forward- thinking, motivated, and have the ability to act independently
Must be able to lift 50lbs minimum
Basic computer skills including Microsoft Office with proficiency in Word and Excel
Problem-solving skills


ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

The work environment characteristics and physical effort described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typically works in a production/clean room environment with adequate lighting and ventilation and a normal range of temperature and noise level.

The associate is required to stand and walk for the majority of the working day. The physical requirements of the job are for associates to talk, hear, bend/stoop, squat, crawl, climb height, reach above shoulder height, crouch, kneel, balance, and push/pull. Furthermore, the job requires associates to lift/carry/push or pull up to 50 pounds with or without assistance. Associates use both hands for repetitive actions such as grasping and manipulating as well as both feet for repetitive movement operating foots controls. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.


The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.

Skills :