Position Summary
Routine Manufacturing operations for the production of clinical and/or commercial products, operation of production equipment according to SOPs and other daily activities on the manufacturing floor
Essential Duties and Responsibilities
Performs manufacturing activities including but not limited to work functions in electromechanical assembly and disposable assemblies (cassettes, cartridges) in a correct and timely manner
Maintains records and controlled-room environment to comply with regulatory requirements, GMPs, and SOPs.
Provide in process testing to assure batches meet specifications. Will train personnel in new and revised procedures
Understand operations and contact appropriate support to ensure issues are appropriately resolved.
Responsible for recommendations for process and system improvements.
Identify process deviations and notify management.
Other related duties as assigned by management
Qualifications
High School Diploma, technical degree or 3-5 years manufacturing experience, operator does not need prior industry experience
Experience in medical device or pharmaceutical industry preferred
Demonstrate a practical understanding of lean manufacturing principles and statistics
Analytical abilities and problem-solving skills
Ability to communicate issues to high management as they arise
Ability to read and understand company quality documents and processes
Sense of urgency and the ability to set and meet deadlines
Must be able to read, write, and communicate fluently in English.
Competencies
Problem Solving-Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Technical Skills-Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Teamwork-Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Quality Management-Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Quantity-Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
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Standard Office & Laboratory Environment