Quality Control Lead Inspector — GMP & FDA Compliance

Swiss American CDMO; Carrollton (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Swiss American Products in Carrollton, TX seeks a Quality Control Inspector Lead Production (QCIP) to assure product conformity with regulatory and quality specs under supervision. You will assign shifts, document checks, and report quality issues to supervision.

Role requires 3–5 years in a QC role within regulated environments, strong communication, leadership, and SAP proficiency, with a focus on detail and collaboration.

Qualifications

• High School Diploma or equivalent required.
• Associate’s degree in quality control, science, or engineering preferred.
• 3–5 years of experience in a regulated quality control role (FDA/USDA).
• Excellent verbal and written communication skills.
• Ability to clearly communicate complex technical information.
• Ability to resolve interpersonal conflicts within the QC Inspector group.
• Strong understanding of math concepts, 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 production processes.
• Sound decision-making to ensure product quality and safety.
• 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.

Responsibilities

• Perform pre-production line inspections to ensure lines are clear of materials from previous runs and ready for use.
• Provide line assignments to all QC inspectors on his/her shift.
• Complete routine production line checks to document fill weights, visual conformity, and seal inspection.
• Collect, document and prepare samples for shipment for microbial and chemical testing.
• Ensure operations in production areas follow SAP SOPs and FDA/GMP guidelines.
• Assist in product/process validation activities.
• Collect and analyze samples for release testing of finished goods and bulk products.
• Monitor production floor to assure adherence to SAP SOPs and FDA/GMP regulations.
• Participate in investigations for deviations and quality failures and implement CAPAs.
• Provide a daily shift summary of production activities and issues impacting conformity.
• Conduct final review of MBRs and ensure records are complete for document control.

Skills

Quality control

Communication

Leadership

Problem solving

Data analysis

Interpersonal conflicts

Attention to detail

Teamwork

Independence

Time management

Documentation

SAP

Microsoft Office

Education

High School Diploma

Associate's Degree in quality control/science/engineering

Tools

SAP

Microsoft Office

QA databases/ software

Job description

Swiss American Products in Carrollton, TX seeks a Quality Control Inspector Lead Production (QCIP) to assure product conformity with regulatory and quality specs under supervision. You will assign shifts, document checks, and report quality issues to supervision.

Role requires 3–5 years in a QC role within regulated environments, strong communication, leadership, and SAP proficiency, with a focus on detail and collaboration.