-
Quality Assurance Representative
2 weeks ago
FST Technical Services Burlington, United StatesJob Description · Job DescriptionFST Technical Services is your global partner in the Semiconductor, Microelectronics, Pharmaceutical and other Life Science Industries Come join an awesome team in an exciting, fast paced, and ever-growing industry · We are looking for Quality As ...
-
Quality Assurance Representative
3 weeks ago
FST Technical Services Burlington, United StatesJob Description · Job DescriptionFST Technical Services is your global partner in the Semiconductor, Microelectronics, Pharmaceutical and other Life Science Industries Come join an awesome team in an exciting, fast paced, and ever-growing industry · We are looking for Quality As ...
-
Food Safety Quality Assurance Intern
4 days ago
Sheetz Burlington, United StatesOVERVIEWVerify that foods produced and assembled in the Sheetz Brothers Kitchen adhere to established high food safety & quality standards and ensure Quality Assurance programs and procedures are implemented and followed. RESPONSIBILITIES (other duties may be assigned)Conduct pre ...
-
Quality Assurance Manager
3 weeks ago
Berkshire Whitsett, United States6509 Franz Warner Pkwy, Whitsett, NC 27377, USA · Job Description · Posted Monday, April 29, 2024 at 4:00 AM · Key Job Functions · Plan, implement, communicate, and maintain the effectiveness of quality programs in compliance with applicable ISO, cGMP, and industry standards. · ...
-
Symbotic Burlington, United StatesWho we are · With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system - reinventing warehouse automation for increased effi ...
-
Quality Assurance Manager
2 weeks ago
MRINetwork Jobs Mebane, United StatesJob Description · Job DescriptionCompany Overview: · Our facility is dedicated to ensuring the safety and excellence of the food products we deliver to consumers. We are committed to fostering a culture of continuous improvement in safety, quality, and efficiency. · Job Descripti ...
-
Quality Assurance Specialist
3 weeks ago
SBM Management Durham, United States Full time· Position at SBM Management · SBM Management is looking for a Quality Assurance Specialist to join our team The Quality Assurance Specialist will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and ...
-
Manager, Quality Assurance
2 weeks ago
Biogen Durham, United States Full timeJob Description · About this role · The Quality Assurance Manager is a fully onsite role responsible for strategic leadership of the Quality Factory Team for small and flexible volume manufacturing providing operational oversight of batch production activities and evaluation, a ...
-
Quality Assurance Technician
2 weeks ago
LanceSoft Mebane, United StatesMonday-Thursday 7am-5:30pmJob Summary:This position is primarily responsible for quality inspection / quality control on the manufacturing production lines. This position is also responsible for execution of incoming inspection. Inspections include visual, dimensional, and functi ...
-
Quality Assurance Manager
4 weeks ago
National Pharmaceutical Durham, United StatesJob DescriptionJob Description · We are seeking a Quality Assurance Manager to become an integral part of our team You will develop and manage our Quality and SOP programs · Responsibilities: · Write corporate SOP's and train staff on appropriate SOP's · Establishing and impl ...
-
Quality Assurance Specialist
2 weeks ago
Piper Companies Durham, United StatesPiper Life Sciences is actively seeking a Quality Assurance Specialist (QA) to help join a team whose mission is to help develop products to cure cancer utilizing cutting edge CAR T-cell technology. Getting to see the impact of your work from bench to patient. This person will su ...
-
Quality Assurance Specialist
1 week ago
Piper Companies Durham, United StatesPiper Life Sciences is actively seeking a Quality Assurance Specialist (QA) to help join a team whose mission is to help develop products to cure cancer utilizing cutting edge CAR T-cell technology. Getting to see the impact of your work from bench to patient. This person will su ...
-
Quality Assurance Manager
4 weeks ago
Xilis, Inc. Durham, United StatesXilis, Inc. is an innovation-driven biotech company developing its proprietary MicroOrganoSphere ("MOS") Technology for functional precision oncology. Xilis' MOS Technology enables rapid and scalable generation of patient tumor models that retain patient-specific tumor biology an ...
-
Quality Assurance Specialist
1 week ago
SBM Management Durham, NC, United States· Position at SBM Management · SBM Management is looking for a Quality Assurance Specialist to join our team The Quality Assurance Specialist will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and ...
-
Fractyl Health, Inc Burlington, United StatesReports to: Senior Manager, Quality Assurance Engineering · Position Summary · Fractyl Health is seeking a highly skilled and experienced Senior/Principal Software Quality Assurance Engineer to join our team. The Senior/Principal QA Engineer will play a critical role in ensuring ...
-
Quality Assurance Technician
1 week ago
Mountaire Siler City, NC, United StatesPrimary Purpose · To complete training on department aspects ensuring food quality, food safety, compliance with S.O.P.s, compliance with FSIS Regulatory, Animal Welfare, and GFSI requirements where product compliance to both internal and customer specifications is key. Animal We ...
-
Quality Assurance Actuary
10 hours ago
Aspida Financial Services LLC Durham, United StatesJob Description · Job DescriptionDescription:Company Description: · Aspida Holdings Ltd., through its subsidiaries (collectively "Aspida"), is focused on providing retirement and reinsurance solutions, having operations in the U.S. and Bermuda with total assets of $12.1 billion a ...
-
Quality Assurance Technician
3 days ago
Mountaire Siler City, NC, United StatesPrimary Purpose · To complete training on department aspects ensuring food quality, food safety, compliance with S.O.P.s, compliance with FSIS Regulatory, Animal Welfare, and GFSI requirements where product compliance to both internal and customer specifications is key. Animal We ...
-
Quality Assurance Technician
4 days ago
Mountaire Siler City, NC, United StatesPrimary PurposeTo complete training on department aspects ensuring food quality, food safety, compliance with S.O.P.s, compliance with FSIS Regulatory, Animal Welfare, and GFSI requirements where product compliance to both internal and customer specifications is key. Animal Welfa ...
-
Quality Assurance Technician
3 days ago
Mountaire Siler City, NC, United States Part timeTo complete training on department aspects ensuring food quality, food safety, compliance with S.O.P.s, compliance with FSIS Regulatory, Animal Welfare, and GFSI requirements where product compliance to both internal and customer specifications is key. Animal Welfare requirements ...
Associate Director of Quality Assurance - Burlington, United States - Kelly Science, Engineering, Technology & Telecom
Description
Kelly Science is seeking a Associate Director of Quality Assurance for a client located near Burlington, MA.This is a full-time, onsite position.
Salary:
$125,000-185,000/year depending on experience
Responsibilities:
Drive expansion of the Quality Management System(s) in the US.
Lead and participate in third party and regulatory audits including preparation and responses.
Oversee qualification of equipment, systems, and suppliers.
Organize and supervise employee training.
Create, revise, and review documents such as SOPs and work instructions.
Oversee and develop CAPA, deviation, risk analysis and change control management.
Communicate with domestic and international pharmaceutical and life science customers and auditors.
Interacting, reporting, and collaborating with PGN Global QA team.
Conduct QA in the company's programs, including ensuring Data Integrity in processes, data packages and reports to the Company's external pharma and gene therapy partners.
Ensure appropriate definition, development, and implementation of Quality systems.Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
Report on Key Quality Indicators (KQI) to track systemic issues and gaps to drive on-going continuous improvement.Job requirements
Scientific or Engineering Degree (BSc, MSc).
Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy.
Extensive experience with GCP/GLP compliance required.Ability to drive cultural changes and establish a strong quality mindset within the organization.
Experience in preparation and participating in inspections by the FDA is and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
Experience leading the accreditation/certification procedures for CAP/CLIA is desirable.Strong quality awareness and ability to apply quality knowledge in practical work.
Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.
Experience in a people management role is strongly preferred.
Prior experience collaborating with outside clients and regulatory bodies preferred.
Excellent verbal and written communication, organizational, and critical thinking skills.
Strong interpersonal skills and the ability to work independently and collaborate in a team setting.
Attention to detail, execution of tasks, and accountability a must.
Must be flexible, willing to take initiative, and highly collaborative.
Integrity, commitment, and a motivated work ethic.
#J-18808-Ljbffr
