Production Technician III - ILP

Key Duties and Responsibilities

• Visual Inspection of product or label printing operations
• Assist preparation of inspection and packaging room materials supplies
• Safely transport product and materials from warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements
• Conduct labeling and the processing of production materials as required
• Investigate and resolve reconciliation issues to advance batches towards closure
• Daily/Bi-Weekly/Monthly cleaning of room and equipment and fill out appropriate preventative maintenance forms and checklists in accordance with SOPs
• Conduct and complete line and room clearances as per established procedures
• Complete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs); comply with cGMPs and company ISO standards
• Daily Supply list for respective area turned into receiving by scheduled time
• Comply with 503B guidelines, cGMPs, and company standards
• Perform equipment calibration checks and troubleshoot equipment as needed
• Complete documentation of activities in accordance with established procedures
• Immediate notification of production management of deviations to established processes or procedures
• Assist other areas as needed (cleaning; non-sterile filling; kitting and preparation operations, etc.)
• Primary, secondary and tertiary labeling of product
• Other duties as assigned

Competencies / Skills

• Communication: Promotes active listening with team members; strong verbal and written communication skills with the ability to work effectively with other departments and people at all levels of the organization
• Problem Solving: Understands how various issues affect each other and the outcome of projects; mechanical aptitude a plus
• Interpersonal Skills: Effectively and productively engages with others and establishes trust, credibility, and confidence
• Customer Orientation: Listens to internal customers, ensures commitments are met, sets appropriate internal customer expectations
• Preferred working knowledge of cGMPs and regulatory requirements as well as all applicable SOPs
• Follows policies and procedures; completes administrative tasks correctly and on time
• Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration; accepts responsibility for own actions; follows through on commitments

Work Environment

• Ability to sit and/or stand 8 hours or more per day if needed
• Ability to manipulate necessary office equipment, computer software, hardware & equipment
• Ability to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking and hearing
• Ability to exert up to 50 pounds of force frequently or constantly to lift, carry, push, pull or otherwise move objects
• Ability to tolerate a work environment that uses cleaning chemicals in order to maintain a sterile manufacturing facility

Hours

• You will be scheduled to work an 8-hour shift during the hours of operation
• Ability to come in prior to scheduled shift hours to support production needs
• Working beyond the scheduled end of your shift is often necessary to complete a production batch and can be required with little or no notice
• Saturdays are expected to be worked when scheduled
• Training may not be scheduled during your normal shift; flexibility to work the hours necessary to complete training is required