Position Summary

Perform visual inspection of the manufactured drug product through the packaging process including visual inspection in compliance with company policies / procedures, Food and Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations. Carry out other Manufacturing & Quality duties when not involved with visual inspection. 

Duties and Responsibilities

• Monitor and perform visual inspections of products and packaging finished product inspections
• Inspection of filled containers, including but not limited to vials, cartridges, syringes according to Standard Operating Procedures (SOPs)
• Follow instructions and ability to perform assigned tasks as given 
• Perform process steps in coordination with other associates
• Adheres to scheduling changes and responds appropriately
• Gives input/makes suggestions to improve process
• Follow all GMP’s and safety procedures
• Attend and completes all mandatory training
• Ensure training plan is accurate and up-to-date
• Ensure qualification status is accurate and up-to-date
• Complete all necessary documentation per the required GMP practices
• Ensure trainer is present as new process steps/equipment are learned
• Ensure any changes noticed in visual inspection are communicated to the next level of Supervision/Lead
• Verify visual inspection rejects of BSM products, as needed 
• Keep work station clean and orderly
• Prepare and stock supplies for visual inspection as needed
• Other duties as assigned 

Regulatory Responsibilities

• Demonstrated knowledge of GMPs, 21 CFR 210/211 & 820 and other regulatory agency requirements sufficient to apply to quality operations and compliance
• Understanding of the basic FDA cGMP regulations

Supervisory Responsibilities

• N/A

Experience

• Zero (0) to two (2) or more years of directly related experience

Education

• Associates Degree or High School Diploma
• Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience

Knowledge, Skills & Abilities

• Excellent verbal and written communication skills 
• Basic software application skills (Word, Power Point)
• Exhibit a quality mindset and a willingness to develop yourself and others
• Satisfactory audio-visual acuity
• Ability to read and write English
• Able to qualify on all BSM visual inspection kits
• Ability to work shifts and off hours, as applicable

Physical Requirements

• Optical vision of 20/20 vision (Snellen chart of equivalent) and near vision acuity (Jaeger 1 at a reading distance approx. 40cm) corrected with lenses where indicated
• No colorblindness
• Must be able to use both hands and arms in repetitive motion as needed
• Must be able to sit at a desk for extended periods of time
• Must be able to use computer related equipment with accuracy and efficiency