Manufacturing Assembly Group Leader (Cincinnati, OH, US, 45241) en Enable Injections | High-Volume Wearable Drug Delivery Systems

Location: Onsite

Status Type: Full Time

Shift: 2nd Shift (M-F 2:00PM-10:30PM EST) 

QUALIFICATIONS

Required:

• Position requires High School diploma or GED
• 3 years of manufacturing experience is required, specifically with the precise assembly of small components per SOPs and GMPs in an FDA Regulated environment
• Ability to read and write fluently in English
• Must be a detail-oriented individual who is highly organized and willing to lead others in a fast paced and constantly evolving environment
• Must have adaptable interpersonal skills and ability to work independently as well as working with others in a team setting Ability to maintain regular attendance and punctuality requirements 
• Willingness and ability to work overtime as needed on both weekdays and weekends
• Ability to maintain regular attendance and punctuality requirements
• Must be able to work with minimal supervision

Preferred:

• 5 years prior experience in the Medical Device or Pharmaceutical industry 
• Experience working in a regulated FDA, or other government agency, environment 
• Experience providing hands-on training to less experienced MATs 
• Prior experince with GMPs and/or sanitation SOPs

Skills & Competencies:

• Intermediate computer skills (Outlook, Word, Excel)
• Ability and willingness to help train and develop Level I and Level II Manufacturing Technicians in a positive and productive manner 
• Ability to read and understand all company procedures and policies 
• Ability to perform basic arithmetic 
• Ability to take direction from supervisors and collectively work with others in a team environment 
• Ability to work in a constantly changing, dynamic work environment.  
• Required to work in a Clean Room (ISO Class 8 or higher) for the entire shift and maintain high standards of personal hygiene 
• Ability to follow Good Documentation Practices to complete documentation in English as needed to record work or inspection data 
• Ability to work as an individual in a team environment where all Technicians are responsible for the quality of finished devices 
• Able to work with little to no supervision  
• Work independently as well as collaboratively with team members as needed

Physical Requirements:

• Ability to work with small parts, using magnification or other visual aids 
• Working in an environment with repetitive motion during the execution of assembly tasks 
• Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time 
• Ability to read and comprehend Quality System Procedures, Operating Procedures, and Inspection Requirements, and demonstrate the execution of tasks to meet Enable Injections Quality System requirements 
• Ability to operate mechanical machinery and inspection equipment 
• Ability to sit and stand for an extended period

Responsibilities:

• Maintain and coordinate daily work assignments and break rotations with manufacturing management oversight
• Verify proper line/material setup and operation at the start of each day and periodically throughout the course of each work order
• Ensure the daily collection and input of manufacturing metrics into efficiency trending tools such as ERP system (SAP) and Excell Spreadsheet
• Conduct daily team huddles at the start of each shift to delegate work assignments and update on production schedule and issues as needed
• Ensure the accurate movement and management of raw materials and finished goods in and out of the manufacturing areas
• Provide MATs with daily routine feedback and coaching as needed pertaining to procedures and quality of work
• Collaborate on the continuous improvement of assembly methods with all other employees as required
• Assembly and packaging of medical products in accordance with documented procedures
• Maintaining a high level of quality and efficiency in the execution of all tasks.  If quality or efficiency issues arise, Manufacturing Assembly Group Leaders are required to notify Enable Injections production supervision and/or management immediately
• Assisting manufacturing and quality assurance with the formal and informal inspection of components, subassemblies, and finished devices while executing tasks
• Adherence to Controlled Environment practices. This includes actively monitoring one’s compliance as well as ensuring anyone in the clean room space is also in compliance
• Performing general cleaning activities for Controlled Environment in accordance with established procedures
• Understanding and executing the Enable Injections Quality Policy and training requirements as they pertain to this job description
• Assisting management with other manufacturing related activities which include organizing materials, loading boxes, counting and recording materials, completing documentation
• Other tasks as required by production management, including but not limited to assembly of tables and other furniture or equipment for manufacturing purposes, cleaning of surrounding manufacturing areas including the warehouse and hallways, etc.