Tech 1, Quality Assurance

Lancesoft; Mebane (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

Lancesoft is seeking a Tech 1, Quality Assurance in Mebane, NC. The role focuses on incoming inspection, data recording, and ensuring sampling plans align with specifications in a fast-paced manufacturing setting.

The incumbent will perform visual, dimensional, and functional inspections, monitor GMP/GDP compliance, and contribute to root-cause investigations while supporting basic lab tasks and maintaining retention samples and device history records.

Qualifications

• High School Diploma or GED with 2 years related QC/manufacturing experience.
• Basic SAP knowledge preferred.
• Experience in FDA regulated environments is desirable.

Responsibilities

• Perform incoming inspection of materials and document results.
• Analyze inspection results against specifications and apply correct sampling plans.
• Identify nonconforming conditions and segregate nonconforming products.
• Ensure GMP/GDP compliance and report infractions.
• Support basic lab tasks, including preparation of standards and reagents.
• Maintain retention samples and device history data storage.
• Work safely following gowning and PPE protocols.
• Participate in Kaizen and continuous improvement activities.

Skills

Incoming inspection

GMP/GDP compliance

Documentation/reporting

Risk assessment

Calibration knowledge

Excel/Word

English fluency

Teamwork

Education

High School Diploma/GED

Tools

SAP

Job description

Title:

Tech 1, Quality Assurance

Location:

Mebane, NC

Shift:

1st Shift;Mon-Thurs;7am-530pm

Description:

• QA will be mostly incoming inspection.
• Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, ensure correct sampling plans are used
• Detect nonconforming conditions during inspection and accurately document each condition.
• 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.
• 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.