Production Technician I – GMP/GDP, Medical Device Assembly

Polyzen, LLC; Apex (NC); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Generous Paid Time Off

Paid Breaks

Annual Bonus

401(K) with excellent company match

Health Insurance with multiple plans  

Paid Short Term and Long Term Disablit

Job summary

Polyzen, LLC is seeking a Production Technician II in Apex, NC. This role focuses on manufacturing high-quality assemblies and sub-assemblies for production and development lines while adhering to GMP/GDP practices.

Ideal candidates have 2–3 years in manufacturing or cleanroom settings and ability to read blueprints, SOPs, and batch records. Microsoft Office experience is expected. On-site position with competitive benefits.

Qualifications

• High School Diploma or equivalent required.
• 2–3 years of experience in a manufacturing or cleanroom environment.
• Knowledge of GMP and GDP.
• Ability to read and interpret working documents such as blueprints, machine manuals, SOPs, and batch records.
• Experience using Microsoft Office.

Responsibilities

• Manufacture and assemble products and sub-assemblies within product specifications and close tolerances for both production and development products.
• Follow all Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) when completing daily tasks.
• Use production travelers and other documentation to identify and confirm raw material accuracy prior to starting manufacturing runs.
• Assist senior-level operators with loading machines, positioning of material, and setting up assembly runs.
• Locate and document production metrics such as yield amounts, tolerance levels, and quality of materials.
• Assist in initial visual inspection of completed manufacturing runs by operating precision measuring equipment.
• Assist with the cleaning of all cleanroom areas including applicable gowning rooms.

Skills

GMP knowledge

GDP knowledge

Mathematics

Communication

Blueprints/SOPs reading

Batch records

Education

High School Diploma or equivalent

Tools

Microsoft Office Suite

Job description

Polyzen, LLC is seeking a Production Technician II in Apex, NC. This role focuses on manufacturing high-quality assemblies and sub-assemblies for production and development lines while adhering to GMP/GDP practices.

Ideal candidates have 2–3 years in manufacturing or cleanroom settings and ability to read blueprints, SOPs, and batch records. Microsoft Office experience is expected. On-site position with competitive benefits.