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Job Summary

Responsible for the co-ordination and reviewing of all batch release activities and documentation in accordance with customer and regulatory requirements prior to final review of documents by QA. Reports directly to the Value Stream Lead or Business Unit Manager. Ensures all batch paperwork is prepared and released in a timely manner for shipping of batches. First point of contact for batch release and shipments in the Business Unit.

Essential Duties and Responsibilities

• Liaise with Planning, Production and shifts to co-ordinate and prioritize batch paperwork
• Ensure all batch paperwork is error free before it leaves the production floor
• Responsible in conjunction with Value Stream lead or Business Unit Manager for establishing performance metrics for the Business unit on batch paperwork
• Ensure metrology and other input documentation required for batch release is up to date and is prioritized in accordance with the batch release and shipping plan. Assist with any correction activities that are required
• Liaise and feedback to Production Supervisor’s and trainer’s issues found during batch paperwork review in a timely manner
• Document and communicate any unplanned delays in batch release and shipments
• Co-ordinate any validation metrology requirements in line with shipping metrology requirements
• Continuously drive improvement projects to deliver competitive advantage for both the Business and customer
• Compliance to all site Environmental, Health and Safety requirements training, and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Education

• High School Diploma or GED required

Work Experience

• Previous production work experience: preferably in a medical device facility or high volume regulated manufacturing environment.
• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.

Preferred Knowledge, Skills and Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications.
• Understanding and experience in use of Lean manufacturing principles.
• Ability to read and interpret documents and drawings, specifications, safety rules, operating instructions, procedure manuals and regulatory documentation.
• Ability to write routine reports, correspondence, and process documents.
• Ability to speak effectively before groups and employees in the organization.
• Ability to understand mathematical concepts such as probability and statistical inference.
• Ability to problem solve.

Travel Requirements

Physical Requirements

Additional Requirements

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.