Posted 1mo ago

Quality Control Inspector Lead (Production)-QCIP

@ Swiss American CDMO
Carrollton, Texas, United States
OnsiteFull Time
Responsibilities:Pre-production inspections, Line assignments, Production checks
Requirements Summary:High school diploma required; associate degree preferred; 3-5 years QC experience in regulated environments (FDA/USDA); strong communication, leadership, problem-solving; SAP knowledge; proficient in MS Office; able to lift up to 50 lbs.
Technical Tools Mentioned:SAP, Microsoft Excel, Microsoft Word, Quality control software, Databases
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Job Description

Position Summary: Under supervision of the Quality Control Supervisor, the Quality Control Inspector Lead Production (QCIP) is responsible for assuring that all products produced at Swiss American Products conforms to all regulatory and quality specifications. The QCIP is also responsible for providing job assignments for his/her shift as well as reporting any quality related issues to his/her supervisor.



Essential Duties and Responsibilities




  • Perform pre-production line inspections to ensure that all manufacturing lines are clear of materials from previous runs and is acceptable for use.

  • Provide line assignments to all QC inspectors on his/her shift.

  • Complete routine production line checks to check and accurately document finished good product for fill weights, visual conformity, and/or seal inspection

  • Collect, document and prepare samples for shipment for microbial and chemical testing.

  • Ensure that all operations in production areas are performed in accordance with SAP SOP’s and FDA/GMP guidelines.

  • Assist in execution of product/process validation activities.

  • Collect and analyze appropriate samples for the release testing of finished goods and bulk products (i.e. pH and Viscosity).

  • Monitor all activity on the production floor to assure adherence to SAP SOP’s and applicable FDA/GMP regulations.

  • Participate in investigations for process deviations and product quality failures and assist in implementation of corrective actions.

  • Provide a daily shift summary of production activities and any issues that may contribute to the manufacture of non-conforming products.

  • Conduct final review of MBR’s priority to submitting to document control for review to ensure that each record is completely and accurately filled out and all activities required by the QC department are fulfilled.

  • Other duties may be assigned.