Manufacturing Operator 3rd Shift

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The Opportunity

The Manufacturing Operator contributes to producing reliable products and supplies with effective operations in an empowered organization. As part of a dynamic team.

Is responsible for collaborating with their team to operate automated equipment and systems to perform a wide variety of complex tasks related to assembly, printing, fill and kitpack manufacturing operations. 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 is in compliance 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. This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.

Responsabilities:

Production

• Executes the process of assembly, filling, labeling & packaging equipment of varying complexity and in with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.
• Performs 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.
• Participates in the execution of protocol/validations.
• Maintains 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

• Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; addresses and escalates any potentially unsafe hazards; provides feedback during investigation of safety hazards, incidents and near misses using safety reporting tools.
• Performs tasks/transactions in the quality system to ensure we achieve our quality objectives.
• Understands the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.
• Maintains accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions).
• Provides feedback on NCR investigations, reworks, and corrective actions.
• Adheres to 95% or above internal training compliance.

Continuous Improvement

• Performs 6S activities, gathers/meets cycle times and develops/follows standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
• Participates and contributes in tier meetings.
• May participate in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.

Teamwork and Collaboration

• Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
• Assists in the successful onboarding of new employees and contractors.

Who you are:

Education:

You hold a H.S. Diploma Or GED as a minimun qualification.

Experience:

2 years of relevant work experience.

Experience with automated manufacturing equipment in a regulated environment. Experience with validated software systems used to maintain Quality, Inventory, and Processes.

Familiarity with sensors, motors, cylinders, etc., and with use of hand tools and test equipment.

Knowledge, Skill or Ability:

• Demonstrated experience with Lean / Continuous Improvement.
• Experience with Google products (gMail, gSheets, gDoc, etc).
• Experience with SAP.
• Ability to work with cross-functional teams.
• Be agile and accurate in a high-volume environment.
• Strong organizational skills, planning skills and attention to detail.
• 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 and use precision tools.
• Ability to have prompt, regular and reliable worksite attendance.

Physical conditions and PPE requirements:

• Stand, walk, sit, kneel,…