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Associate Manufacturing Operator

3 months ago

Marana, United States LanceSoft Full time

Associate Manufacturing Operator Job Description

Summary:
Our operations are critical to the success of our company and our impact on society. This contractor role is part of an industry-leading organization helping patients to obtain on-time and reliable diagnostics. Doing now what patients need next.

The individual in this role contributes to producing reliable products and supplies with effective operations in an empowered organization. This contractor role is responsible for operating automated equipment and systems to perform a wide variety of tasks related to assembly, printing, fill and kitpack manufacturing operations.

Responsibilities:

Production (80%)
- Executes the process of assembly, filling, labeling & packaging equipment of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates, instruments, 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).
- 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 Client 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 in shop floor tier meetings.

Teamwork and Collaboration (5%)
- Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
Other duties as assigned.

Education/Experience:
- High School Diploma/GED, required
- Associates Degree (preferred)
- 2 years relevant work experience, preferably in GMP environment
- Experience with automated manufacturing equipment in a regulated environment, preferred.
- Experience with validated software systems used to maintain Quality, Inventory, and Processes, preferred.
- Familiarity with sensors, motors, cylinders, etc., and with use of hand tools and test equipment, preferred.

Knowledge Skills and Abilities:
- Demonstrated experience with Lean / Continuous Improvement
- Experience with Google products (Gmail, gSheets, gDoc, etc), preferred
- Experience with SAP preferred
- Ability to read, write and comprehend English
- 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 daily production goals
- 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 the essential functions.

- Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.
- Required to push, pull, and lift a minimum of 30 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 manipulate heavy equipment, tools and supplies; to concurrently manipulate multiple controls and machinery; and to wear and work in personnel protective equipment.
- Depending on the work area, may be required to wear personal protective equipment, for example: lab coat, shoe covers, ear protection, safety glasses, and/or face shield.
- This is an essential position supporting the organizational goals requiring attendance on weekends, holidays and during emergency or exceptional conditions.