דרושים Production Supervisor Assembly ב-West Pharma ב-United States, Tempe

Management and implementation of facility projects and support in holistic building management. Perform a wide variety of mechanical, as well as pneumatic maintenance activities and some basic electrical activities on various pieces of equipment to maintain safe operations of equipment while maintaining production goals and quality standards. Other responsibilities include sourcing parts for obsolete parts and ordering them, documenting all the maintenance activities performed, PM's, installation, and validations of equipment. Will support and help other groups like Process Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. Work from prints, sketches, sample parts, verbal or written instructions. Interpret drawings, select material plan, and layout work in proper operational sequence. Maintain and setup vision systems during production.

• Identify problems by reading schematics/prints, where available, and make necessary repairs on the equipment or system to ensure safe operation of the machine or system.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS guidelines for printing machines.
• Perform necessary oil changes on machine gear boxes and dispose of used oil per established procedure.
• Rebuild/retrofit machine or machine components as per specifications.
• Perform installation, replacement or decommissioning of equipment.
• Perform validations as necessary for equipment.
• Work with training department to train new mechanics on machine repair, setup and related plant procedures.
• Complete PM's on or before the due date and communicate to proper authority of job completion.
• Source obsolete parts for equipment and make them stock item.
• Identify and locate parts in the stock room through MP2 or other such system.
• Participate in various company run programs like Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each shift.
• Safeguard all corporate or plant confidential information.
• Use good housekeeping practices to maintain safe, (safe is always first) clean, orderly work area.
• Upgrade technical skills by various educational workshops, on-site or off-site trainings supported by WEST.
• Follow engineering department guidelines and procedures.
• Conforms with and abides by all safety rules, regulations, policies, work procedures and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required

• • Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for production area personnel. Resolves employee issues through problem resolution.
  • Responsible for ensuring applicable training and compliance associated with work area and products.
  • Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift, ensuring that quality requirements are being fulfilled.
  • Provides feedback to proper departments regarding production, quality, engineering, and personnel issues.
  • Direct and assists training of all production floor positions; topics include, but not limited to: SOPs, WIs, SPCs, and FDA regulations.
  • Ensures work areas are kept clean, orderly, and safe. Makes frequent safety inspections with follow-through reporting and/or corrective actions, including work related injuries.
  • Responsible for finalizing all necessary data that is required for a timely, shift-to-shift transition, ensuring completeness and accuracy.
  • All interactions, workflow, productivity levels, and quality standards are implemented with a “Customer Service” approach to both internal and external customers.
  • Assists in the decision-making process in regard to cycle standards and process changes.
  • Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
  • Supervise shift personnel in the manufacture of customer products consistent with high quality and safety standards.
  • Troubleshoot problems arising on the shop floor as it relates to injection molding product quality and automation systems for throughput and yields with the appropriate engineering support from Engineering functions within the value stream / business unit
  • Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule.
  • Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant employees.
  • Recommend and implement measures to motivate employees and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
  • Routinely evaluate employee performance and identify training needs. Coach and counsel employees for performance, attendance and behavior. Participate in the resolution of employee relations issues.
  • Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each employee has worked.
  • Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders with consistent focus on labor absorption.
  • Ensure SOPs, cGMP, OSHA and Safety regulations are followed.
  • Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
  • Liaise with internal and external customers and other departments as appropriate.
  • Participate in special project teams as assigned.
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all laws, regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance.

• Bachelor's Degree or equivalent experience in technical or business related field required

• Minimum 5 years Must have a minimum of 5 years’ experience in a manufacturing environment, including supervisory experience required and
• Experience with SAP systems preferred

• Working knowledge of injection molding / plastics manufacturing and electro – mechanical automated systems.
• Knowledge of manufacturing processes within clean room environment, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.
• Must possess strong leadership and managerial skills
• Knowledge of and ability to work in appropriate computer programs and applications
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Health Services\First Aid Certification Certification in First Aid Upon Hire preferred or
• Health Services\Cardiopulmonary Resuscitation (CPR) CPR Upon Hire preferred

• Manufacturing environment
• Occasionally required to work on different shifts.
• Regularly uses hands and fingers to operate objects, tools or controls. Frequently required to stand, talk and hear for long periods of time.
• Specific vision abilities may be needed by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• 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
• Other duties as assigned

• High School Diploma or GED Required

• Minimum one year manufacturing experience required

• Must poses an acute attention to detail
• Basic computer skills

• 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

In this role, you will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. This role is on-site (Monday through Friday) from 10:00 pm to 6:00 am.

• Able to train, provide trouble shooting guidance/feedback, and problem resolutions on metrology equipment including but not limited to CMM’s (Coordinate Measurement Machine), Vision Systems, and manual gaging.
• Proactively analyze data and interpret results for any trending or OOS (out of specification) events.
• Provides direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, documentation review, and calibration to support Operations and release of product.
• Identifies and develops opportunities to improve existing processes and procedures.
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Assist in and manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. Advise on equipment condition, test method, etc. to aid in the course of action when components do not meet specifications. Responsible for quality inspection and verification.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non‐Conformance Report is required.
• Assist in developing documentation and procedures during the qualification of new equipment/inspection methods.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

Education or Equivalent Experience: Associate’s Degree in Technical or Engineering

• 5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration Control (or a formal education equivalent) required.
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Metrology/Manufacturing background and Risk Management preferred.
• Experience with quality systems such as ISO 13485 and 21 CFR 820 preferred.
• Experience with MasterControl, SAP, and SharePoint preferred.
• Experience with customer interface and meeting customer expectations preferred.
• 3+ years of supervisor experience preferred.

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
• Familiarity with root cause analysis tools.
• Working knowledge of MasterControl and SAP.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
• Able to comply with the company’s safety policy at all times.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to 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.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.

• 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