QC Inspector II

Trividia Health, Inc.•Fort Lauderdale, FL

About The Position

SUMMARY • Inspect and release raw materials and chemicals used in the manufacturing and packaging of THI product, • Determine the conformance of ancillary products and sharps then release approved lots for distribution • Liaise with QC III and above to initiate a non-conforming for rejected lots per QSR-13-00. • Perform the opening, in-process and closing of work orders in Packaging. • Rotate between receiving and packaging inspection every two months (day shift personnel only) ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Receiving Inspection • Inspect and release raw materials per the applicable SOP and sampling plan (daily) • Perform and document UDI Inspection as applicable • Print and apply approved labels to released raw materials, chemicals and ancillary items • Report to QCIII and above when lots are rejected so they can be processed in accordance with QSR-13-00. • File completed receivers after the approval and release of inspected lots. Packaging Inspection • Inspect and release packaged product per QSI-10-00. • Perform Line Open inspection of work orders to be packaged per the work order instructions. • Verify part number, revision levels, lot numbers and expiration dates of materials match the bills of materials associated with each work order to be packaged. • Perform UDI grading and verification on product labelling and packaging when applicable • Ensure any additional materials brought to the line match the bills of materials. • Verify packaged product is assembled in accordance with applicable work instructions and bills of material • Verifies labels and labeling are in accordance with the applicable bills of material and workorder instructions. • Perform in-process inspection randomly during the packaging run. • Close Work Orders • Inspects imprints, samples, and ensure final documentation is correct and complete. • Initiate a nonconforming report for rejected lots, with the assistance of a QC III Inspector or higher per QSR-13-00. • Print and apply Green Approved labels to released pallets of product. • Releases final packaged product for transfer and trucking to shipping. • Perform related duties and assignments including but not limited to the following: o Keep training in proquis and compliance wire current o Perform rework per NCN disposition and approved RWI o Assists with the segregation and disposal of Scrap and obsolete materials o Change the status of items on restricted status in QAD when requested with documentary evidence • Assists the Department Supervisor by initiation or the request to perform related assignments • Follow all Safety and Environmental Regulations as required by THI.

Requirements

One year certificate from college or technical school; or three to six months related experience and/or training; or equivalent combination of education and experience.
Intermediate computer skills.
Ability to read and comprehend simple instructions, short correspondence, and memos.
Ability to write simple correspondence.
Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Ability to calculate square root, add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
Ability to deal with problems involving a few concrete variables in standardized situations.

Responsibilities

Inspect and release raw materials per the applicable SOP and sampling plan (daily)
Perform and document UDI Inspection as applicable
Print and apply approved labels to released raw materials, chemicals and ancillary items
Report to QCIII and above when lots are rejected so they can be processed in accordance with QSR-13-00.
File completed receivers after the approval and release of inspected lots.
Inspect and release packaged product per QSI-10-00.
Perform Line Open inspection of work orders to be packaged per the work order instructions.
Verify part number, revision levels, lot numbers and expiration dates of materials match the bills of materials associated with each work order to be packaged.
Perform UDI grading and verification on product labelling and packaging when applicable
Ensure any additional materials brought to the line match the bills of materials.
Verify packaged product is assembled in accordance with applicable work instructions and bills of material
Verifies labels and labeling are in accordance with the applicable bills of material and workorder instructions.
Perform in-process inspection randomly during the packaging run.
Close Work Orders
Inspects imprints, samples, and ensure final documentation is correct and complete.
Initiate a nonconforming report for rejected lots, with the assistance of a QC III Inspector or higher per QSR-13-00.
Print and apply Green Approved labels to released pallets of product.
Releases final packaged product for transfer and trucking to shipping.
Keep training in proquis and compliance wire current
Perform rework per NCN disposition and approved RWI
Assists with the segregation and disposal of Scrap and obsolete materials
Change the status of items on restricted status in QAD when requested with documentary evidence
Assists the Department Supervisor by initiation or the request to perform related assignments
Follow all Safety and Environmental Regulations as required by THI.