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About the role
Key responsibilities & impact- Scan and inventory source plasma units assigned to production units using a barcode reader.
- Visually inspect plasma units and remove unsuitable units, including damaged units, broken ports/tubes, RBC, and other rejection categories.
- Use the Plasma Management System (SGP) to remove, block, transfer, label, and process plasma units.
- Identify and block units that do not meet customer requirements.
- Transfer unreleased or unsuitable units into sub-shipments and correct reject inventory.
- Verify sub-shipment identification and location at the end of the production process.
- Scan archive sample vials and complete partial production-unit cases.
- Enter abnormalities using the SGP Statistics function.
- Monitor plasma time out of the freezer using the SGP warning system.
- Clear production lines between completed production units and perform end-of-process line clearances.
- Maintain cGMP compliance, cleanliness, organization, safety, and record accountability.
- Scan cases/units for third-party sale and MDO processes using the Disposition Module.
- Transfer units between production units/lots and process unsuitable plasma during any step.
- Perform secondary verifications and end-of-line clearances as a Certified Inspector.
- Work with minimal supervision while meeting throughput standards.
- Cross-train in Material Handling to support efficient plasma operations.
Requirements
What you’ll need- High School Diploma or equivalent.
- Certified Inspector: Two years’ experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is required.
- Associate Inspector: One year experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable.
- Experience with cGMPs and Industry Standards; required knowledge for Certified Inspector and desirable for Associate Inspector.
- Ability to read, understand, and follow Standard Operating Procedures/written procedures.
- Good verbal and written communication skills.
- Basic math skills: addition, subtraction, division, and multiplication.
- Basic computer skills.
- Microsoft Word/Excel, Outlook Email, Microsoft Teams, and file management.
- Ability to understand spoken and written instructions.
- Ability to make fast, simple hand and arm movements to maintain production pace.
- Exceptional attention to detail.
- Certified Inspector knowledge of SGP Status codes, Disposition Codes, and labeling requirements.
- Ability to meet department throughput standards.
- Ability to work rotating shifts and in a manufacturing environment.
- Ability to perform required physical duties, including standing/walking 6–8 hours, lifting up to 50 lbs, bending, twisting, frequent hand movements, and use of personal protective equipment.