Tech 2 Quality Assurance

Job Title: Quality Assurance Technician II

Location: 1022 Corporate Park Way, Mebane, NC 27302

Duration: 12 Months

Shift: Monday-Thursday 9pm-7am

Job Summary:

This position is primarily responsible for quality inspection/quality control on the manufacturing production lines. This position is also responsible for execution of incoming inspection. Inspections include visual, dimensional, and functional inspections on a wide variety of products. This position monitors compliance to 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 cause 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.

Job Responsibilities:

Independently perform and document final inspection of all production slides, vials, kits, and labels to established quality specifications, and make independent determination of acceptability for release.

Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, ensure correct sampling plans are used.

Work with production associates to ensure materials utilized are released and correctly accounted for, line verification is performed prior to start of production, verify accuracy and completeness of documentation, and confirm equipment used meets designated specifications including calibration.

Work with manufacturing personnel to accurately complete required Quality Control (QC) testing, documentation and determine correct disposition.

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, 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 change 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.

Work Environment:

Associate must be present at designated shift start-up times to ensure smooth production operation.

Schedule may need to flex based on business needs that require nontraditional work hours

(10-hour shifts / 4 days per week).

Ability to periodically work overtime as production needs require.