We have other current jobs related to this field that you can find below
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Quality Specialist
2 days ago
durham, United States Net2Source Inc. Full timeJob Description: Quality Specialist - I (Assistant)Location: Durham, NC 27712Duration: 12+ Months (Extendable)Pay Rate: $36/hr on W2Qualifications:Education Minimum Requirement: High school degree is the minimal requirement, but bachelor’s degree in a scientific discipline is preferred. Technical emphasis in an appropriate Scientific or Engineering field...
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Quality Specialist
2 weeks ago
Durham, United States Net2Source Inc. Full timeJob Description: Quality Specialist - I (Assistant)Location: Durham, NC 27712Duration: 12+ Months (Extendable)Pay Rate: $36/hr on W2Qualifications:Education Minimum Requirement: High school degree is the minimal requirement, but bachelor’s degree in a scientific discipline is preferred. Technical emphasis in an appropriate Scientific or Engineering field...
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Quality Specialist
1 day ago
durham, United States Net2Source Inc. Full timeJob Description: Quality Specialist - I (Assistant)Location: Durham, NC 27712Duration: 12+ Months (Extendable)Pay Rate: $36/hr on W2Qualifications:Education Minimum Requirement: High school degree is the minimal requirement, but bachelor’s degree in a scientific discipline is preferred. Technical emphasis in an appropriate Scientific or Engineering field...
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Quality Specialist
1 week ago
Durham, United States Net2Source Inc. Full timeJob Description: Quality Specialist - I (Assistant)Location: Durham, NC 27712Duration: 12+ Months (Extendable)Pay Rate: $36/hr on W2Qualifications:Education Minimum Requirement: High school degree is the minimal requirement, but bachelor’s degree in a scientific discipline is preferred. Technical emphasis in an appropriate Scientific or Engineering field...
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Quality Specialist III
1 month ago
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Senior Software Release and Build Specialist
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Durham, North Carolina, United States Serigor Inc Full timeJob Title: Senior Software Release and Build Specialist (HYBRID)Location: Remote Duration: Long-term contract positionJob Overview:Facilitate the development, automation, and execution of application portfolios.Oversee infrastructure management, environment setups, build and deployment processes, and resolve build-related challenges.Conduct build and...
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Specialist, Quality Assurance
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Durham, North Carolina, United States Merck Full timeJob DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our success is backed...
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Agile Release Train Leader
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Durham, North Carolina, United States The Clorox Company Full timeAbout The Clorox Company:At Clorox, we are dedicated to fostering growth for our employees and our brands. Our commitment to our purpose and values places people at the forefront of everything we do, enabling each individual to positively influence consumers, communities, and colleagues.Your Role:We are currently seeking a seasoned Agile Release Train...
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Senior Quality Control Technician
1 month ago
Durham, North Carolina, United States Baebies Inc Full timeThe position performs routine and non-routine analytical testing and performs regular data entry and analysis for lot release of in vitro diagnostic products, assays and reagents.Responsible for in line production quality assurance inspections, batch record (device history record) reviews, and product release.Collect and enter data on batch records and into...
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Quality Inspector
2 months ago
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Quality Assurance Technician
3 months ago
Durham, United States restor3d Full timeJob DescriptionJob DescriptionJob Summary:The Quality Assurance Technician will be responsible for assisting in maintenance and implementation of the quality system of the company. Along with day-to-day assistance in release of product.Essential Duties and Responsibilities:Develop and maintain strong, internal working relationships across both North and...
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Quality Inspector
1 month ago
Durham, United States Carolina Components Group Full timeJob DescriptionJob DescriptionTitle: Quality Inspector Job Type: Full timeLocation: Durham, NC 27703Summary: The Quality Inspector is responsible for ensuring process, material, and assembly compliance to customer specifications, ISO 9001, cGMP, and Carolina Components Group standards. The individual is responsible for understanding and...
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(7 / 21) Senior Quality Control Technician
1 month ago
Durham, United States Baebies Inc Full timeThe position performs routine and non-routine analytical testing and performs regular data entry and analysis for lot release of in vitro diagnostic products, assays and reagents.Responsible for in line production quality assurance inspections, batch record (device history record) reviews, and product release.Collect and enter data on batch records and into...
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Microbiology Quality Control Specialist
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Software Quality Assurance Specialist
7 days ago
Durham, North Carolina, United States AICPA Full timeSoftware Quality Assurance SpecialistAICPADurham, North CarolinaA highly driven and skilled professional responsible for overseeing, executing, and enhancing the overall quality assurance (QA) results through meticulous planning, control, and execution of testing to support various methodologies including Agile, Scrum, Waterfall, and Hybrid processes. This...
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Quality Assurance Specialist, Cell
4 weeks ago
Durham, United States Piper Companies Full timePiper Life Sciences is actively seeking a Quality Assurance Specialist to join a cell &gene therapy organization developing innovative AAV platform products for challenging diseases. The Quality Assurance Specialist will be responsible for the review and approval of data in a GMP environment. This is a Monday - Friday, traditional hours role that is...
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Sr. Software Build Release Admin
3 months ago
Durham, United States Serigor Inc. Full timeJob DescriptionJob DescriptionJob Title: Sr. Software Build Release Admin (HYBRID)Location: Durham, NCDuration: 12+ MonthsJob Description:The client requires the assistance of a contract resource to serve as a Senior Build/Release Administrator to support the development, Automation, and implementation of portfolio applications. This position will be...
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Durham, North Carolina, United States Piper Companies Full timePiper Companies is currently in search of a Quality Assurance Specialist to become a part of a cell and gene therapy organization that is pioneering advanced AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP setting. This position...
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Senior Quality Assurance Specialist
3 months ago
Durham, United States HUMACYTE GLOBAL INC Full timeJob DescriptionJob DescriptionSenior Quality Assurance Specialist Position ProfileHumacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham,...
Quality Product Release Specialist
2 months ago
Look for candidates with Minimum 4+ years of experience as Quality Product Release Specialist.
Experience in GMP-related field, including Technical, Engineering, Quality or Operations.
Position Description / Skill Set Required:
The Quality Product Release Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. Execution of the activities and responsibilities related to this position are designed to further develop the knowledge and skill foundation required to advance to other Quality-based functions within the organization.
The Quality Product Release Specialist, with guidance from the IPT Quality Release Lead, ensures product / process quality, performs activities to facilitate the release of product to the marketplace, and ensures proper control of material.
The Quality Product Release Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area. Specific responsibilities include but are not limited to the following:Becomes fully trained in Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
Learns cGMPs, the manufacturing process, and quality systems.
Responsible for the review and release of filled container batches destined for both domestic and international markets.
Prepares and submits release protocols. Prepares CoAs to support regulatory filings.
Works cross-functionally to resolve outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material.
Ensures compliance with departmental procedures.
Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
Ensure proper identification of release status and control of materials through maintenance of batch and stock status in SAP and through physical tagging of material, as required.
Assists with training of new team members.
Cross trains to support other functional quality areas, including but not limited to deviation management, environmental monitoring investigations, and inspection support.
Required Experience and Skills:
A minimum of four years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
Evidence of leadership skills coupled with good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
Effectiveness and creativity in approaching and solving technical problems.
Attention to detail, flexibility and an awareness of production and quality control problems.
Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, MS Outlook, and/or MS Word)
Preferred Experience and Skills:
Familiarity with vaccine and/or pharmaceutical processing.
Familiarity with batch dispositioning (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.
Education Minimum Requirement: Bachelor’s degree. Technical emphasis in an appropriate Scientific or Engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.Location Preference:
Durham, NC
