דרושים Production Operator ב-United States, Arizona, Scottsdale

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

• Under the supervision of a trainer or supervisor perform the following duties...
• process trimmed product through washing and drying process per site SOI’s and work instructions.
• Ensure that the equipment is set up accurately.
• Ensure continual flow of product through the module from the mold press thru the trim press.
• Operate a mold press to produce molded panels of product following site SOI’s and work instructions.
• Operate a manual / automatic trim press as needed following site SOI’s and work instructions.
• Process product through any required special treatments such as sort, silicone, chlorination, etc.
• As needed, set up pack scales for weighing and packing of finished product and prepare carton labels for boxing and shipping.
• Alert the Area Supervisor to conditions that may prevent meeting production and quality expectations.
• Accurately maintain all required documentation and paperwork to ensure product traceability.
• Inspect molded/trimmed work to ensure quality product is being produced.
• Move materials into and out of the area as required.
• Properly clean and prep assigned workstations/equipment during and prior to the next available shift.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

• High School Diploma or GED Required

• No min required

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English

• Ensure that the equipment is set up accurately.
• Ensure continual flow of product through the module from the mold press thru the trim press.
• Operate a mold press to produce molded panels of product following site SOI’s and work instructions.
• Operate a manual / automatic trim press as needed following site SOI’s and work instructions.
• Process trimmed product through washing and drying process per site SOI’s and work instructions.
• Process product through any required special treatments such as sort, silicone, chlorination, etc.
• As needed, set up pack scales for weighing and packing of finished product and prepare carton labels for boxing and shipping.
• Alert the Area Supervisor to conditions that may prevent meeting production and quality expectations.
• Accurately maintain all required documentation and paperwork to ensure product traceability.
• Inspect molded/trimmed work to ensure quality product is being produced.
• Move materials into and out of the area as required.
• Properly clean and prep assigned workstations/equipment during and prior to the next available shift
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Exhibits qualities of a leader, owning the responsibilities and desiring to help the department to meet its goals.
• Work in a manner that promotes good working relationships throughout the department.
• Prioritize and delegate work to team members keeping criticality of the operation in mind. Helping and sharing workload with all the team members is important responsibility of the Production Operator Lead.
• Communicating critical issues and equipment release to operations after completion of work, helping other groups like QA for investigations, projects for engineering etc.
• Safeguard all corporate or plant confidential information
• Performs other duties as assigned based on business needs.

• High School Diploma or equivalent required
• Bachelor's Degree or working towards preferred

• Minimum 5 years required

• Computer skills- Microsoft Office

• Under the supervision of a trainer or supervisor perform the following duties...
• process trimmed product through washing and drying process per site SOI’s and work instructions.
• Ensure that the equipment is set up accurately.
• Ensure continual flow of product through the module from the mold press thru the trim press.
• Operate a mold press to produce molded panels of product following site SOI’s and work instructions.
• Operate a manual / automatic trim press as needed following site SOI’s and work instructions.
• Process product through any required special treatments such as sort, silicone, chlorination, etc.
• As needed, set up pack scales for weighing and packing of finished product and prepare carton labels for boxing and shipping.
• Alert the Area Supervisor to conditions that may prevent meeting production and quality expectations.
• Accurately maintain all required documentation and paperwork to ensure product traceability.
• Inspect molded/trimmed work to ensure quality product is being produced.
• Move materials into and out of the area as required.
• Properly clean and prep assigned workstations/equipment during and prior to the next available shift.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

• High School Diploma or GED required

• No min required

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English