Excipient Operator 3rd shift

Job Description

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)



Minumum 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