Title:  Investigation specialist

Job Summary

Essential Duties and Responsibilities

• Responsible for determining daily, weekly, and long-term manufacturing activities.
• Follows process, supports closure of area deviations and investigations, and contributes to implementation of appropriate CAPAs.
• Actively participates/contributes improvements to technology transfer, start-ups, design, and implementation of process changes, typically working on cross-functional teams.
• Follows cGMPs. Ensure plant and equipment are maintained to best possible working condition.
• Support customer relations’ efforts by meeting customer standards and delivery dates. Participate in resolving customer problems, takes a new perspective using existing solutions and reinforces the marketing department’s customer relations program.
• Follows established methods and means for handling, storage, packaging, and delivery of products to prevent damage and deterioration. Solves range of straightforward problems.
• Uses best practices and knowledge of internal or external business issues to support Operational Excellence Management and participate on the OpEx initiatives.
• Consistently participates in the plant safety program, lean initiatives, training program and HR policies. Acts as a resource for colleagues with less experience within these programs.
• Participate in customer audits, customer complaint investigations, plant tours, etc. as requested or required.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.

Additional Responsibilities

• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Other duties as assigned based on business need.

Education

• Bachelor's Degree In a technical Discipline to include: Business, operations or engineering. required

Work Experience

• Minimum 3 years Pharmaceutical manufacturing experience required
• Experience working with ISO standards, FDA and cGMP required

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.