Quality Control Technician
Company: Antylia Scientific
Location: Buffalo
Posted on: June 24, 2025
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Job Description:
Job Description Job Title: Technician, Quality Reports To:
Manager, Quality Position Location: Buffalo, NY FLSA Status:
Non-Exempt Position Summary: 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. Key
Responsibilities: /n - Responsible for performing final QC checks
on all outgoing product shipments, which includes reviewing and
assuring accuracy of both documentation and product. /n -
Responsible for release of incoming materials, manufactured
materials, and finished products according to written
specifications. /n - Assist with the maintenance of the equipment
qualification and calibration program and upkeep of the equipment
database. /n - Assist the QA/QC Manager with review and filing of
calibration certificates, out of tolerance reports, deviations, and
SCARs as necessary. /n - Assist with the development and
implementation of company SOPs as assigned. /n - Perform document
control and training activities as assigned. /n - Requires an
ability to complete cGMP documentation accurately, in accordance
with standard operating procedures, and in a timely manner. /n -
Requires an ability to work independently to accomplish given tasks
within given timelines. /n - Requires an ability to multitask and
adjust to changing priorities. /n - Must report any deviations or
nonconformities immediately to a Manager or Director. /n - Other
duties as assigned. /n /n Education: - Associate's Degree in
related field or equivalent work experience /n Experience: - 1 or
more years of previous related experience /n Minimum
Requirements/Qualifications: /n - Good communication and
organizational skills and ability to multitask. /n - Prior
experience with ISO 13485 and 21 CFR 820 a plus. /n - Thrives in a
fast-paced, collaborative environment, efficiently works under
pressure, within deadlines or other time essential constraints /n -
Excellent communication skills, both written and verbal, to clearly
and concisely communicate to all levels of the organization /n -
Strong work ethic and an ability to excel within a rapidly changing
and growing organization /n /n Physical Requirements/Working
Conditions: - Control exposures to hazardous chemicals & other
safety hazards such as: /n - Carcinogens. /n - Strong and obnoxious
fumes. /n - Sharp and dangerous blades and needles. /n - Biohazard
exposure to specimens. /n /n /n Compensation & Benefits: /n -
Salary Range: $22/hr-$24/hr, depending on location, experience, and
qualifications. /n - Benefits coverage begins day 1, including the
following: /n - Medical, Dental, Vision Insurance /n - Disability
Insurance /n - Life Insurance /n - 401(k) company match /n - Paid
Time Off (15 days annually) /n - Paid Holiday time (10
company-designated days) /n - Tuition Assistance /n - Additional
benefits available with company package /n /n /n /n 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.
Keywords: Antylia Scientific, Buffalo , Quality Control Technician, Accounting, Auditing , Buffalo, New York