Tech 1, Quality Assurance

TechDigital Group; Mebane (NC); On-site; USD 42,000 - 62,000; Full time

Job summary

TechDigital Group seeks a QA Inspector to execute incoming inspections and monitor GMP/GDP compliance in a fast-paced manufacturing environment in North Carolina. The role includes sampling, label verification, documenting nonconformances, and supporting basic lab activities.

Strong attention to detail and the ability to work independently are essential. The position requires at least a high school diploma (or GED) with 2 years of QC/manufacturing experience and familiarity with SAP and Excel.

Qualifications

• High School Diploma or GED with at least 2 years related QC or manufacturing experience.
• Basic knowledge of SAP is preferred.
• Experience in an FDA-regulated environment is highly desirable.

Responsibilities

• Independently perform incoming inspection of a wide variety of materials, analyze inspection results against specifications, and ensure sampling plans are used.
• Independently inspect labels used in production to ensure alignment with specifications.
• Detect nonconforming conditions during inspection and document each condition, segregating nonconforming products.
• Perform basic lab support functions, including preparation of standards and reagents, and handling hazardous waste as appropriate.
• Maintain retention samples and electronic/physical storage of device history records.
• Work safely following gowning and PPE procedures.
• Participate in continuous improvement activities (e.g., kaizen).
• Additional responsibilities as assigned by management.

Skills

Attention to detail

Observation skills

Teamwork

Written communication

Independent work

Education

High School Diploma or GED

2 years QC/manufacturing experience

Tools

SAP

Microsoft Excel

Job description

This position is primarily responsible for execution of incoming inspection. Inspections include visual, dimensional, and functional inspections on a wide variety of products. This position monitors compliance with GMP and GDP, and reports infractions appropriately. Additional responsibilities include analysis of results, product sampling, label verification, determining product disposition, detecting nonconforming conditions, investigating root causes of nonconforming conditions, and accurately recording and reporting quality data. This role is responsible for working within an established framework of compliance and implementing improvements to product quality and the quality system.

• Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, ensure correct sampling plans are used.
• Independently perform inspection of labels used in the production of products to ensure alignment with specifications.
• Detect nonconforming conditions during inspection and accurately document each condition. Demonstrate a bias for action to determine scope of nonconforming conditions, and segregate nonconforming products to prevent further use.
• Perform basic lab support functions, including preparation of basic standards and reagents, Obtaining samples from production, PM, 5S, and cleaning and handling of hazardous waste as appropriate.
• Responsible for maintenance of retention samples, and electronic and physical storage of device history records.
• Must perform work in a safe manner adhering to gowning and PPE procedures.
• Participation in continuous improvement activities is required (e.g. kaizen).
• Additional responsibilities as assigned by management.

Education and Experience:

• High School Diploma/GED with a minimum of 2 years related QC or manufacturing experience.
• Basic knowledge of SAP is preferred.
• Experience working in an FDA regulated environment is highly desirable.

Knowledge and Skills:

• General Proficiency in Microsoft Office
• Demonstrated understanding of sampling techniques and inspection standards.
• Basic math skills and the ability to utilize Excel for basic calculations and graphing.
• Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
• Excellent observation skills with a bias for "corrective action” and improve work environment processes and procedures.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance.
• Ability to assess and articulate risk when evaluating a situation.
• Knowledge of basic validation, equipment calibration, and changing requirements.
• Demonstrated understanding of the use of calibrated equipment.
• Proven capability to prioritize responsibilities and complete tasks on schedule.
• Must be able to work independently in a fast-paced manufacturing environment.

Physical Demands:

Ability to stand for long periods of time. Ability to lift 25 lbs. Ability to do repetitive motion.