Quality Control Technician

COLE-PARMER INSTRUMENT COMPANY•Buffalo, NY

5d•$22 - $24•Onsite

About The Position

Responsible for quality system processes designed to ensure continuous flow of incoming and outgoing materials consistent with established standards and regulations including FDA 21 CFR 820, ISO 13485, and appropriate EU regulations. Ensures compliance in QC areas including review and generation of information for incoming materials and product release. Ensures compliance in the areas of equipment qualification and calibration, supplier qualification and management, and document control as needed. Ensures continued improvement and compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, and deviation, nonconformance, complaint, and CAPA processes as necessary. Promotes and participate in training activities related to the quality management system and product quality, safety and efficacy.

Requirements

Good communication and organizational skills and ability to multitask.
Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
Strong work ethic and an ability to excel within a rapidly changing and growing organization
Associate’s Degree in related field or equivalent work experience
1 or more years of previous related experience

Nice To Haves

Prior experience with ISO 13485 and 21 CFR 820 a plus.

Responsibilities

Responsible for performing final QC checks on all outgoing product shipments, which includes reviewing and assuring accuracy of both documentation and product.
Responsible for release of incoming materials, manufactured materials, and finished products according to written specifications.
Assist with the maintenance of the equipment qualification and calibration program and upkeep of the equipment database.
Assist the QA/QC Manager with review and filing of calibration certificates, out of tolerance reports, deviations, and SCARs as necessary.
Assist with the development and implementation of company SOPs as assigned.
Perform document control and training activities as assigned.
Requires an ability to complete cGMP documentation accurately, in accordance with standard operating procedures, and in a timely manner.
Requires an ability to work independently to accomplish given tasks within given timelines.
Requires an ability to multitask and adjust to changing priorities.
Must report any deviations or nonconformities immediately to a Manager or Director.
Other duties as assigned.