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Cole-Parmer Technician, Quality in Buffalo, New York

Job Title: Technician, Quality

Reports To: Manager, Quality Assurance

Position Location: Buffalo, NY

FLSA Status (Exempt/Non-Exempt): Non-Exempt

Position Summary:

The Quality Assurance Technician role is an entry to mid-level position within the Quality Assurance and Regulatory Affairs Department of ZeptoMetrix.

Key Responsibilities:

  • Maintain existing profiles, configure new features and troubleshoot reported issues for our eQMS system, MasterControl.

  • Execute validation of equipment; apply knowledge to author validation protocols for IQ/OQ/PQ for Equipment Validation Procedures, maintain validation program

  • Form a detailed understanding of products, the Quality Management System, procedures, and Regulatory requirements in order to complete routine processes as required including Deviations, NCM’s, CAPA’s, and Complaints.

  • Performing duties as directed in compliance with SOPs and regulations outlines in ISO, CFRs, and other applicable federal, state, and local regulations

  • Maintain active communication with the Manger to facility Quality updates as needed

  • Perform other related duties as assigned

    Education:

  • High School diploma, GED or equivalent experience

    Experience:

  • 2-5 years of prior relevant experience

    Minimum Requirements/Qualifications:

  • Good organizational skills

  • Attention to detail

  • Thrives on the opportunity to excel

  • Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints

  • Prior experience with ISO 13485 and 21 CFR 820 or working in a regulated environment

  • 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

    This position has not been approved for Relocation Assistance.

    The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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