Manufacturing Operator II

Kelly Services; Fremont (CA); On-site; USD 25,000 - 36,000; Full time

Job summary

Kelly Services is seeking a Manufacturing Operator II in Fremont, CA to support production and meet company goals. The role involves equipment operation, material setup per work orders, documentation, and teamwork within a manufacturing services environment.

The ideal candidate has 1+ year experience in manufacturing, familiarity with cGMP, and proficiency in Word/Excel. This position requires flexibility for overtime and varying shifts to support production needs.

Qualifications

• High School Diploma or equivalent required.
• Minimum of 1 year of direct work experience in manufacturing.
• Direct experience in a cGMP environment preferred.
• Knowledge of Microsoft Word and Excel is required.
• Ability to use QAD and Oracle for document printing and production scheduling.
• Ability to read, write and comprehend English; good arithmetic skills.

Responsibilities

• Set up and operate production floor equipment under supervision.
• Read and understand work orders; verify materials per job.
• Manufacture and test complex products following cGMP and document activities.
• Assist production lead in job assignments and line staffing.
• Close and seal containers, label products, and manage containers.
• Enter material use data in the QAD system and perform line clearance.
• Maintain clean, sanitized work areas and follow safety procedures.
• Collaborate with Production Lead and Sr Operator to resolve scheduling issues.
• Support process improvement and equipment validation activities.
• Follow SOPs and report discrepancies; participate in Lean and 5S activities.

Skills

Teamwork

English proficiency

Mathematical ability

Communication

Education

High School Diploma

Tools

QAD

Oracle

Excel

Word

Job description

Finding a job that fits your lifestyle isn't always easy. That's where Kelly comes in. We're seeking a Manufacturing Operator II to work at a premier client in Fremont, CA, 94538.

Job Details

Job Duration: 12 Months

Shift: 6:00AM to 2:45PM (Mon-Fri)

Note;

Must be flexible to support overtime, weekend overtime

Must be available to support stagger shift (9am-5:45pm) and

Must be available to support swing shift hours (4:00 PM–4:00 AM) based on production needs and supervisory assignment.

Job Description

The Operator II position will interact and work closely with production leads and managers within Manufacturing Services department to support production demand and ensure achievement of company goals following the 4i values.

Job Responsibilities

Responsible for signatures as review on SOP’s and other work instruction documents.

Understands and can communicate workflow and technologies used in the production environment.

Manufacture and/or test complex products following cGMP and completes all vital documentation in accordance with Quality System. Records information such as time and date performed.

Share standard process.

Set up and operate production floor equipment including troubleshooting and adjustments under the direction of a Production Operator Lead or Supervisor

Read and understand work orders to successfully set up materials on-line, verify and count the amounts required as per work order.

Inspect material and products at each set up of production process.

Assist the Production Operator Lead in the assignment of jobs as required by their assignment on the production line.

Close and seal containers, sort bundles or filled containers, label containers, container tags, or products as needed.

Pack special arrangements or selections of products as needed.

Make necessary entries in the QAD System related to material use.

Line Clearance – responsible to reconciliation and disposal of materials related to the job.

Clean and sanitize work areas, machines and printers as needed or directed.

Work with Production Lead, Production Operator II’s and Sr Operator as a team to solve Production Floor scheduling, equipment, and logistic issues.

Support Engineer in process improvement and equipment validation activities.

Responsible for following ISO/cGMP Quality System Regulations with focus on SOP completion accuracy, product quality, and housekeeping activities.

Follow all written procedures. Report discrepancies in procedures (SOP's, batch records, etc.) to the Area Supervisor and perform all work activities in a safe manner and wear personal protective equipment as required.

Participate in Practical Process Improvement (PPI), Lean, and 5-S programs while working with other departments to troubleshoot processes/procedures to deliver recommended solutions

Perform other job duties as required by department and/or Management

Keys to Success

High School Diploma or equivalent required.

Minimum of 1 year of direct work experience in manufacturing, operations, production, lab setting.

Preferred

Direct experience in a cGMP environment, Good Documentation Practices (GDP), and Good Warehouse Practices.

Direct machine operation experience.

Knowledge of Microsoft Word and Excel is required.

Ability to use electronic management systems such as QAD and Oracle to print all required documents to complete the daily work as indicated in the production schedule.

Ability to read, write and comprehend English language, both written and verbally.

Ability to read and interpret as related to documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to understand and carry out instructions furnished in written, oral, or diagram form.

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

Ability to handle multiple tasks and react appropriately to changing priorities and impending deadlines.

Must be highly collaborative in teamwork environment.

Ability to perform basic math.

Ability to stand for sustained periods of time

Physical Requirements / Work Environment

Able to lift up to 50 lbs. without assistance.

May work in cold environments (as low as -20C) and around loud-noise equipment.

Personal protective equipment (PPE) such as steel-toe shoes, lab coats, gloves, safety glasses, and ear protection required.

Controlled Substance Handling: This role involves handling, management, and oversight of controlled substances (Schedules I–V) in accordance with DEA, FDA, and Thermo Fisher guidelines.

Exposure to Controlled Substances: Proper safety protocols and protective measures must be strictly followed.

Safety Protocols: Adherence to all safety procedures is mandatory to ensure a safe working environment.

Background Check: Successful completion of a background check, including screening related to controlled substances, is required.

Benefits and Resources

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Kelly

You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and affirmative action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.