Manufacturing Visual Inspector

SHARP STERILE MANUFACTURING LLC•Lee, MA

About The Position

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.

Requirements

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

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