Quality Assurance Inspector

Summary

Checks filling lines and incoming packaging materials to ensure they meet specifications in a GMP manufacturing environment.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Samples and inspects packaging material components for kits, packaging and labeling for compliance to documented specifications.

• Performs line clearance activities to assure that materials not suitable for current and subsequent operations have been removed.

• Verifies properly documented sanitization activities and filling/packaging equipment set-up parameters.

• Verifies product released for filling/packaging; verify lot number and expiration date.

• Performs in-process material sampling and inspection activities according to sampling plan (i.e. fill weights, seal integrity, torque and visual inspection for defects).

• Monitors labeling and packaging operations, including inspecting the first unit assembled for correctness of packaging, labeling, instructions and all markings by comparing to Packaging Specifications.

• Ensures all materials are labeled as to their inspection and test status.

• Ensures Master Filling/Packaging Batch records are completed in their entirety by all associated personnel.

• Confirms Quality Control released final product.

• Inspects final packaged product to determine compliance with procedures and order specifications; releases product for shipping.

• Complies with cGMP, EHS guidelines, and all working procedures assigned to the position.

• Performs other tasks, as assigned.

Competencies

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

High school diploma or general education degree (GED) required; or one to three months related experience and/or training; or equivalent combination of education and experience. Working knowledge of ISO, FDA, and cGMP concepts and guidelines and prior experience in a Medical Device or other Quality Assurance related industry preferred.

Language Skills

Ability to read and comprehend instructions and correspondence. Ability to write correspondence. Ability to effectively present information in one-on-one and small group situations.

Mathematical skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Must be able to pass internal mathematical exam.

Reasoning Ability

Demonstrated ability to work accurately, follow instructions, schedules, and timelines and handle multiple priorities. Ability to deal with problems involving a few concrete variables in standardized situations.

Computer Skills

Ability to utilize word-processing, spreadsheet and database applications including MS Office applications (Word, Excel and Outlook).

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is frequently required to stand. The employee is occasionally required to sit. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Pay Range

The Quality Assurance Inspector is a non-exempt position that is paid hourly. Pay rate will be dependent on a number of factors including but not limited to knowledge, skills, and experience.

EEO Statement

Dental Technologies Inc. is proud to be an equal opportunity employer.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.