Manufacturing Operator III, UD Fill B1 7AM-7:30PM

Role Summary

Manufacturing Operator III, UD Fill B1 7AM-7:30PM. Manage production lines to meet the established production schedule in accordance with Standard Operating Procedures (SOP’s) and Good Manufacturing Principles (GMP’s) while monitoring product to ensure quality standards are maintained.

Responsibilities

• Comply with all safety regulations and conduct all activities in a safe, efficient manner.
• Apply 5S and cGMPs in all areas of responsibility.
• Operate high-speed equipment for the manual or automated assembly, filling, packaging and labeling of pharmaceutical products: ensuring adherence to specifications.
• Perform tasks that may be verified by an independent individual; or perform inspection/verifications of work performed by others.
• Clean packaging rooms and machinery in accordance with SOPs and cGMPs.
• Conduct Set-Ups, in-process actions, data entry, and other computer-related tasks.
• Complete batch records accurately and documents production volumes in accordance with SOP‚Äôs and cGMP‚Äôs.
• Accept or reject products according to acceptability standards determined by cGMP‚Äôs, customer requirements, and SOP‚Äôs.
• Complete Line Clearances and Change Overs on production lines in accordance with SOP‚Äôs and cGMP‚Äôs.
• Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy and accountability.
• Perform other duties as assigned.

Qualifications

• High School Degree or equivalent with one year of manufacturing experience.
• One (1) year of related work experience, preferably in a high-speed production or manufacturing environment.
• Experience working in a GMP regulated environment preferred.
• Basic user knowledge of Microsoft Office, SAP experience preferred.
• Experience working in an Aseptic Production environment preferred.

Essential Knowledge, Skills & Abilities

• Detail-oriented and self-motivated.
• Excellent hand-eye coordination and manual dexterity.
• Excellent math skills; ability to add, subtract, multiply, and divide.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or oral instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• Ability to work any shift (up to 12-hours) as required dependent on business needs.
• Physically able to continuously stand and walk.
• Ability to work in a controlled environment and comply with gowning requirements such as: hairnets, beard covers, safety shoes, googles and/or safety glasses.
• Ability to interpret work instructions and standards of work independently.
• Physically able to lift up to 40 lbs.
• Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
• Effective and efficient operation of manual and automated production equipment.
• Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.