Job Summary
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 ... Job Details
This position will be responsible for the following:
• Comply with all safety regulations and conduct all activities in a safe, efficient manner.
• Apply 5S and cGMP's 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.
• Operates high-speed flow wrap equipment to support continuous workflow.
• Conduct serialization tasks, such as in-process inspections for production orders.
• 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 SOP's and cGMP's.
• 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's and cGMP's.
• Accept or reject products according to acceptability standards determined by cGMP's, customer requirements, and SOP's.
• Complete Line Clearances and Changeovers on production lines in accordance with SOP's and cGMP's.
• Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy.
• Examine finished product, document test results, and determine product acceptability based on specifications.
• Perform other duties as assigned.
Education and Experience:
Minimum requirements for this position are:
Education
High School Degree or equivalent with one to two (1 - 2) years of manufacturing experience.
Experience: Technical
Two (2) years of related work experience, preferably in a high-speed production or manufacturing environment.
Experience: Regulatory
Experience working in a GMP regulated environment preferred.
Experience: Systems
Basic user knowledge of Microsoft Office, SAP experience preferred.
Experience: Aseptic
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.
• Ability to obtain and maintain Sr. Certified Operator Certification.
• 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.
B1 Shift - 7am-7pm Thursday/Friday/Saturday & every other Wednesday
