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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Civica Rx Petersburg, United StatesAbout Civica · Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical i ...
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
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Quality Assurance Engineer
2 weeks ago
Donatech Clearwater, United StatesPosition would require the candidate to be a W2 employee of Donatech. · US Citizenship Required. · Applies quality principles in the areas of: design, incoming material, production control, product evaluation, program performance, reliability, inventory control, and/or research ...
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Quality Assurance Engineer
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The Staffing Resource Group Inc Clearwater, United StatesJob Description · QA Engineer · SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing i ...
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Civica Rx Petersburg, United States Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical indu ...
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Quality Assurance Engineer
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civica rx Petersburg, United States Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. · Civica is led by an experienced team of healthcare and pharmaceutical i ...
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Quality Assurance Engineer
2 days ago
Civica Rx Petersburg, United States Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical indu ...
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Quality Assurance Engineer II
1 week ago
Civica Rx Petersburg, United StatesAbout Civica · Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical i ...
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Quality Assurance Engineer II
1 week ago
Civica Rx Petersburg, United StatesAbout Civica · Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical i ...
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Senior Quality Assurance Engineer
2 weeks ago
Raymond James St Petersburg, United StatesThis position will follow our hybrid work model, we expect the selected candidate to be in office 2-3 days a week at the St. Petersburg, FL office location. · Job Summary: · This position is part of our enterprise QA team focused on automation. The position requires a self-moti ...
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Quality Assurance Engineer II
2 days ago
civica rx Petersburg, United States Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. · Civica is led by an experienced team of healthcare and pharmaceutical i ...
Quality Assurance Engineer - Petersburg, United States - BioSpace Recruitment Services
1 week ago
Description
Position Summary
We are looking for a Quality Assurance Engineer who will be responsible in maintaining the company's quality systems, equipment, facility, and processes to ensure they are run in accordance with GMP regulation and site procedures.
Duties & Responsibilities
Working across functions, to ensuring the site's quality system processes related to GMP compliance of the facility, equipment, computer systems and processes.
Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
Works across functions to develop and implement processes.
Ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation and site procedures.
Required Qualifications
Bachelor's degree in a scientific discipline with a minimum of 7 years Quality/cGMP experience in the pharmaceutical industry. Experience in facility and equipment qualification, process validation, computer system validation, and calibration and maintenance programs. Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required. Strong project management, organization, and execution skills to manage multiple projects and priorities. Participation and leading activities to support regulatory agency inspections required. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment. Ability to work autonomously and within established guidelines, procedures, and practices. Serve as a Quality subject matter expert to support driving investigations to root cause. Leverage experience and share industry best practices to support continuous improvement of site procedures. Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters. Continuously looking for opportunities to learn, build skills and share knowledge with others. Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
Preferred Qualifications
Experience across the product development and commercialization lifecycle. Technical expertise in sterile pharmaceutical isolator technology, and combination product.