Third Party Quality Senior Associate The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products ...
Third Party Quality Senior Associate The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products ...
associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health ... Support Quality Assurance operations and ensure compliance with current Good Manufacturing ...
associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health ... Support Quality Assurance operations and ensure compliance with current Good Manufacturing ...
associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health ... Support Quality Assurance operations and ensure compliance with current Good Manufacturing ...
associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health ... Support Quality Assurance operations and ensure compliance with current Good Manufacturing ...
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Job ID: (790543) Jr. QA Consultant Location: Atlanta, GA Duration: 12+ Months Client: GDOT Hybrid ... Certified Associate in Software Testing (CAST) * Certified Test Engineer (CSTE) * Certified ...
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QA Consultant
Atlanta, GA · On-site
Job ID: (790543) Jr. QA Consultant Location: Atlanta, GA Duration: 12+ Months Client: GDOT Hybrid ... Certified Associate in Software Testing (CAST) * Certified Test Engineer (CSTE) * Certified ...
QA Coordinator
$20 - $24/hr
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QA Coordinator
$20 - $24/hr
Job Title: QA Coordinator Company Location: - Suwanee, GA 30024, USA Shift and Pay: This is a 1st shift position from 7:00am-3:30pm, pay is between $20-$24 DOE Roles and Responsibilities: As a QA ...
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$130K - $165K/yr
The QA Lead acts as the final quality gate before code reaches production and our customers, including CTIA and the broader wireless ecosystem. This is a high-visibility role with direct impact on ...
QA Lead
Atlanta, GA · On-site
$130K - $165K/yr
The QA Lead acts as the final quality gate before code reaches production and our customers, including CTIA and the broader wireless ecosystem. This is a high-visibility role with direct impact on ...
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Atlanta, GA · On-site
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Quality Assurance Manager
Atlanta, GA · On-site
As a Quality Assurance Manager , you will lead efforts ensuring our products consistently meet Quality Control (QC) and Quality Assurance (QA) performance standards - from raw material qualification ...
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Alpharetta, GA · On-site
We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
Quality Assurance Manager
Alpharetta, GA · On-site
We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
Quality Assurance Manager
Alpharetta, GA · On-site
We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
Quick apply
Quality Assurance Manager
Alpharetta, GA · On-site
We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
Meet the team Our Coordinator Quality Assurance plays a critical role in supporting our Operations partners in damage prevention and quality assurance initiatives. As a result, we hold ourselves to ...
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We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have ...
Overview Job Purpose We are seeking a QA Engineer with experience in testing LLM based software. As a member of the QA team, you will have the opportunity to participate in various projects where ...
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Quality Management * Develop, implement, and maintain quality assurance programs and procedures to ensure compliance with local, state, and federal regulations Auditing and Monitoring * Conduct ...
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QA Lead
Alpharetta, GA · On-site
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Gainesville, GA · On-site
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Quality Assurance Manager The Quality Assurance Manager (QA) plays a critical role in risk prevention, safety and compliance, all of which help ensure operational excellence across BBMA's portfolio ...
Quality Assurance Manager
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Quality Assurance Manager The Quality Assurance Manager (QA) plays a critical role in risk prevention, safety and compliance, all of which help ensure operational excellence across BBMA's portfolio ...
Quality Assurance Manager
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Quality Assurance Manager The Quality Assurance Manager (QA) plays a critical role in risk prevention, safety and compliance, all of which help ensure operational excellence across BBMA's portfolio ...
Quality Assurance Manager
Atlanta, GA · On-site
Quality Assurance Manager The Quality Assurance Manager (QA) plays a critical role in risk prevention, safety and compliance, all of which help ensure operational excellence across BBMA's portfolio ...
Quality Management * Develop, implement, and maintain quality assurance programs and procedures to ensure compliance with local, state, and federal regulations Auditing and Monitoring * Conduct ...
Quick apply
Quality Management * Develop, implement, and maintain quality assurance programs and procedures to ensure compliance with local, state, and federal regulations Auditing and Monitoring * Conduct ...
Quality Assurance Analyst AssuranceAmerica is seeking a Quality Assurance Analyst to join our growing ranks as we continue to transform the way technology impacts the insurance business. You will ...
Quality Assurance Analyst AssuranceAmerica is seeking a Quality Assurance Analyst to join our growing ranks as we continue to transform the way technology impacts the insurance business. You will ...
QA Engineer
$120K - $140K/yr
We are seeking a QA Engineer to lead quality assurance across our software products and help ensure we deliver reliable, high-quality experiences for customers. This person will own test strategy ...
Quick apply
QA Engineer
$120K - $140K/yr
We are seeking a QA Engineer to lead quality assurance across our software products and help ensure we deliver reliable, high-quality experiences for customers. This person will own test strategy ...
Qa Associate information
See Bethlehem, GA salary details
$11.49 - $15.44
17% of jobs
$16.74 is the 25th percentile. Wages below this are outliers.
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The median wage is $21.36 / hr.
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8% of jobs
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5% of jobs
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3% of jobs
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0% of jobs
$47.02 - $50.97
0% of jobs
$50.97 - $54.92
0% of jobs
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$54
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Full-time
Re-posted 6 days ago
Job description
Third Party Quality Senior Associate
Job Description
The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products manufactured by external third parties in accordance with site SOP and regulatory guidance. The position will also perform the quality review of related cGMP documentation for Alora distributed products, including annual product reviews, and will assist with the coordination of global change controls.
Key Responsibilities/Essential Functions
- Critically review and disposition batch record documentation for products manufactured by external third parties.
- Perform the quality review of related cGMP documentation generated at third parties including, but not limited to deviations, out-of-specification investigations, change controls, process validation protocols/reports, and master batch records.
- Assign and/or approve lot numbers and expiration dates for products transferred to packaging facilities, as required.
- Review annual product reviews generated by third party vendors. Collect, review, and report product data needed to supplement third-party vendor annual product reviews.
- Collect and review the changes to USP and initiate any associated change controls related to those changes. Assist with the execution of a corporate USP change management system.
- Monitor and assist with the implementation of new corporate policies.
- Collect and review the changes to regulatory policies and assist in the implementation of these policies.
- Review and approve product labeling.
- Escalate issues to Quality Management, as appropriate, including, but not limited to, product quality, safety, or efficacy concerns identified in annual product reviews and critical issues identified as part of batch record review and related records.
- Track closure of assigned Third Party Quality records.
- Monitor due dates for submission of annual product reviews and perform follow-up activities.
- Assist with the generation of quality system metrics and trending reports.
- Assist with the performance of high-risk or global risk assessment impacting Alora manufactured and/or distributed products.
- Assist with the development and maintenance of procedures that define the cGMP activities within the areas of responsibility.
- Provide training and guidance to more junior Associates within the Third Party Quality team.
- Champion quality improvement processes within the areas of responsibility to ensure adherence to cGMPs and foster continuous improvement.
- Support a culture of quality and continuous improvement throughout the organization.
- Perform additional duties and responsibilities as assigned by Quality Management.
Basic Qualifications
- A Bachelor's degree preferred and/or 4 years of related work experience.
- Minimum of 2 years of quality experience in FDA regulated industries (pharmaceutical or biotech industries, preferred).
- Thorough knowledge of FDA Quality System requirements.
Other Requirements
- Ability to work independently when guided by documented procedures.
- Able to work effectively as part of a team.
- Excellent attention to detail.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Strong oral and written communication skills.
- Proficient with Microsoft office applications.
About Avion Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Alpharetta, GA, US
Year founded
2011