Title: Manufacturing Operator Location: Santa Clara, CA (95050) Standard Shift: 8-5 pm Duration: 5 Months
Summary: The Manufacturing Operator contributes to producing reliable products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Manufacturing Operator is responsible for collaborating with their team to operate automated equipment and systems to perform a wide variety of complex tasks related to assembly, in-line testing, cleaning, and packaging manufacturing operations. Manufacturing Operator recognizes and elevates safety, equipment, and product problems, contributing to the achievement of production goals. Utilizes validated software and systems to maintain processes, batch records, and inventory control. Ensures all production-related documentation complies with quality system regulations. May be responsible for low complexity training of new employees and sharing best practices. They must have good communication and organizational skills and the ability to identify opportunities that would drive the business forward.
Responsibilities: Production (80%)
Executes the process of assembly in-line testing, cleaning and packaging of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.
Capable of basic transactions within highly complex systems and controls in a regulated manufacturing environment (e.g. receive, process, build product/materials, facilitate material availability, SAP transactions/confirmations).
Runs automated systems/equipment and sequences of operation, including: equipment setup, operation, and cleaning; monitoring and performing basic troubleshooting.
Participate in the execution of protocol/validations.
Ability to be a subject matter expert (SME) in one or more areas of production. Contributes to daily end of shift reports and pass downs.
Safety and Quality (10%)
Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner;
Address and escalate any potentially unsafe hazards; Provides feedback during investigation of safety hazards, incidents and near misses using safety reporting tools.
Perform tasks/transactions in the quality system to ensure we achieve our quality objectives.
Understand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.
Maintain accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions)
Provide feedback on NCR investigations, reworks, and corrective actions.
Adhere to 95% or above internal training compliance.
Continuous Improvement (5%)
Responsible for 6S activities, gathering/meeting cycle times and developing/following standard work;
identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
Participates and contributes to tier meetings.
May participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.
Teamwork and Collaboration (5%)
Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
Assisted in the successful onboarding of new employees and contractors.
Other duties as assigned.
Education/Experience:
High School Diploma/GED, required
Associate degree (preferred)
2 years of relevant work experience, preferably in a GMP environment
Experience with automated manufacturing equipment in a regulated environment, is required.
Experience with validated software systems used to maintain Quality, Inventory, and Processes, required.
Familiarity with the use of hand tools and test equipment, is required.
Knowledge Skills and Abilities:
Demonstrated experience with Lean / Continuous Improvement
Experience with Google products (Gmail, GSheets, GDoc, etc), preferred
Experience with SAP required
Ability to read, write, and comprehend English
Ability to work with cross-functional teams
Ability to be agile and accurate in a high-volume environment
Strong organizational skills, planning skills, and attention to detail
Strong communication skills - written, verbal
Strong critical thinking, problem-solving, and analytical skills
Excellent time management skills to manage multiple tasks and competing timelines
Ability to use the technology associated with the industry.
Ability to use precision tools
Ability to have prompt, regular, and reliable worksite attendance.
Physical conditions and PPE requirements:
The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Required to stand, walk, sit, kneel, bend, crouch for a combined 8 or more hours per day.
Required to push, pull, and lift a minimum of 50 pounds.
Repetitive, consistent movements of the wrists, hands, and/or fingers.
Required to have good near visual acuity to perform activities throughout the processes in the assigned area.
Must be able to work in, on, around, over, and under fixed equipment and machinery; to work from lifts and ladders; to manipulate heavy equipment, tools, and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.
This is an essential position supporting the organizational goals requiring attendance on some weekends, holidays, and during emergency or exceptional conditions.
Required to work and handle hazardous chemicals and adhere to all PPE Requirements
Notice to California Applicants: SPECTRAFORCE® is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2024; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $25.00/hr.
