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
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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
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Supervisory Responsibilities | |
Experience | - Zero (0) to two (2) or more years of directly related experience
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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
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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
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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
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