Manufacturing Visual Inspector

Job Title

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.