Quality Control Inspector Lead (Production)-QCIP

Swiss American CDMO•Carrollton, TX

3d•Onsite

About The Position

Under the supervision of the Quality Control Supervisor, the Quality Control Inspector Lead Production (QCIP) is responsible for ensuring that all products produced at Swiss American Products conform to all regulatory and quality specifications. The QCIP is also responsible for providing job assignments for their shift and reporting any quality-related issues to their supervisor.

Requirements

High School Diploma or equivalent required.
3-5 years of experience in a Quality Control role within a regulated environment (FDA, USDA).
Excellent verbal and written communication skills.
Ability to clearly and effectively communicate complex technical information.
Ability to effectively resolve interpersonal conflicts within the QC Inspector group.
Strong understanding of mathematical concepts, including fractions, percentages, ratios, and proportions.
Familiarity with rounding rules and significant figures.
Strong analytical and problem-solving skills.
Ability to interpret and apply SAP protocols to various production processes.
Ability to make sound decisions and take decisive action to ensure product quality and safety.
Ability to identify and resolve quality issues promptly and effectively.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Familiarity with relevant quality control software and databases.
Strong leadership and mentorship skills.
Excellent organizational and time management skills.
Ability to work independently and as part of a team.
Strong attention to detail and accuracy.

Nice To Haves

Associate's Degree in a relevant field (e.g., Quality Control, Science, Engineering) preferred.

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.