Quality Assurance Specialist jobs in Gainesville, FL

Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Quality Assurance Specialist II
  • Beacon Therapeutics
  • Gainesville, FL FULL_TIME
  • Mission
    The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.

    Reporting Relationship
    • The Quality Assurance Specialist will report directly to the Associate Director of Quality Assurance or designee.

    Duties and Responsibilities
    • Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs
    • Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
    • Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
    • Write, review and revise standard operating procedures
    • Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements
    • Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
    • Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
    • Review and approve Certificates of Analysis and/or Certificates of Test
    • Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations and investigations.
    • Track open observations and Corrective and Preventative Actions (CAPA) to closure.
    • Assist with the analysis of trends and metrics to ensure continuous quality improvements.
    • Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
    • Other duties as assigned.
    • This job description is subject to change at any time.

    Educational Qualifications
    • Level I - B.S. degree in a scientific discipline and no QA experience
    • Level II - B.S. degree in a scientific discipline and at least two (2) years’ QA experience (5 preferred) in a GLP/GMP environment, preferably in a biotechnology company
    • Level III - B.S. degree in a scientific discipline and at least five (5) years’ QA experience (7 preferred) in a GLP/GMP environment, preferably in a biotechnology company

    Additional Qualifications
    • In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
    • Great attention to detail
    • Strong interpersonal skills
    • Strong prioritization, organizational and negotiating skills
    • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
    • Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines

    Physical Requirements
    • Physical demands: (check one)
    ☐ sedentary (< 10 lbs.)
    ☒ light work (< 20 lbs.)
    ☐ medium work (< 50 lbs.)
    ☐ heavy work (< 100 lbs.)
    ☐ very heavy work (> 100 lbs.)
    • Physical activity: (check all that apply)
    ☒repetitive motion
    ☐ balancing
    ☐stooping
    ☒lifting
    ☐climbing
    ☒kneeling/crouching
    ☐crawling
    ☒reaching
    ☒standing
    ☒ typing/grasping
    ☒walking
    ☒pushing/pulling
    ☒hearing
    • Visual acuity: reading, writing, preparing/analyzing data
    • Working conditions: indoor office environment and lab area

    Supervisor Responsibilities
    • This position does not require previous supervisory experience.
  • Just Posted

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Quality Assurance Systems Specialist III
  • Beacon Therapeutics (USA) Inc
  • Alachua, FL FULL_TIME
  • If you are passionate about ensuring quality standards are met in the biotech industry, this Full-Time Quality Assurance Systems Specialist III position at Beacon Therapeutics (USA) Inc is the perfect...
  • 21 Days Ago

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Quality Assurance / Quality Co
  • cromcorp
  • Gainesville, FL FULL_TIME
  • Job Title Quality Assurance / Quality Co Location Gainesville - Gainesville, FL 32607 US (Primary) Job Type Full-time Job Description N/A
  • 3 Days Ago

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Quality Assurance Document Controller
  • Arcosa Brand
  • Sumterville, FL FULL_TIME
  • Arcosa Traffic Structures is looking for a Quality Assurance Document Controller. In this role, you will support the Quality Assurance team by providing various office and location support activities....
  • 10 Days Ago

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Quality Assurance Manager
  • Green Thumb
  • Ocala, FL FULL_TIME
  • The Role The Quality Assurance Manager is responsible for managing and enforcing all quality assurance and (QA) operations at GTI’s Ocala, Florida production facility. Specifically, the QA Manager wil...
  • 10 Days Ago

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Quality Assurance Technician
  • St. Johns Ship Building
  • Palatka, FL FULL_TIME
  • POSITION SUMMARY This position is responsible for auditing and validating all aspects of the organization’s quality assurance (QA) compliance. The position will lead efforts to enhance quality of serv...
  • 1 Day Ago

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0 Quality Assurance Specialist jobs found in Gainesville, FL area

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QUALITY ASSURANCE DIRECTOR
  • Hiring Now!
  • Ocala, FL
  • The Judge Group is partnered with a well established food manufacturer with well-known brands in the consumer packaged g...
  • 4/16/2024 12:00:00 AM

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Treating Plant Specialist- Quality Control
  • Robbins Manufacturing Company
  • Lake City, FL
  • Job Description Job Description As a Treating Plant Specialist-Quality Control at Robbins Manufacturing, you will play a...
  • 4/16/2024 12:00:00 AM

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Entry Level Engineer - Water/Wastewater
  • Jones Edmunds
  • Alachua, FL
  • Job Type Full-time Description At Jones Edmunds, the Entry Level Engineer(Engineer Intern) applies engineering education...
  • 4/16/2024 12:00:00 AM

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Associate Director, Quality Assurance Operations
  • Beacon Therapeutics (USA) Inc
  • Alachua, FL
  • Join our dynamic team at Beacon Therapeutics (USA) Inc. as a Full Time Associate Director in Quality Assurance Operation...
  • 4/15/2024 12:00:00 AM

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Quality Control Technician - 3rd shift
  • Pulley Salty Snacks LLC
  • Ocala, FL
  • Job Description Job Description ***Must be available for training for two weeks (M-F 8am - 4pm)*** ***After training, em...
  • 4/14/2024 12:00:00 AM

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OPS Dental Assistant
  • University of Florida
  • Gainesville, FL
  • Classification Title: OPS Dental Assistant Job Description: The College of Dentistry is accepting applications for an OP...
  • 4/13/2024 12:00:00 AM

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Quality Assurance Manager
  • Hiring Now!
  • Gainesville, FL
  • We are seeking an experienced Quality Assurance Manager to join our team in a fast-paced food/beverage manufacturing env...
  • 4/12/2024 12:00:00 AM

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Assistant Quality Assurance Manger
  • Hiring Now!
  • Lake City, FL
  • Description:A growing food company located near Vidalia, GA is currently searching for an Assistant Quality Assurance Ma...
  • 4/12/2024 12:00:00 AM

Gainesville is located at 29°39'55" North, 82°20'10" West (29.665245, −82.336097), which is roughly the same latitude as Houston, Texas. According to the United States Census Bureau, the city has a total area of 62.4 square miles (161.6 km2), of which 61.3 square miles (158.8 km2) is land and 1.1 square miles (2.8 km2) is water. The total area is 1.74% water. Gainesville's tree canopy is both dense and species rich, including broadleaf evergreens, conifers, and deciduous species; the city has been recognized by the National Arbor Day Foundation every year since 1982 as a "Tree City, USA". Gain...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$55,647 to $70,452
Gainesville, Florida area prices
were up 1.5% from a year ago

Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020