Quality assurance [h1.location_city]
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Quality assurance • cambridge ma
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The Manager of Quality Assurance is responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system which supports clinical developmen...[show_more][last_updated.last_updated_30]
Associate Director, Quality Assurance.Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells.We have brea...[show_more][last_updated.last_updated_30]
We believe in the power of ingenuity to build a positive human future.As strategies, technologies, and innovation collide, we create opportunity from complexity.
Our diverse teams of experts combine...[show_more][last_updated.last_updated_30]
This role is primarily responsible for day-to-day operations within the Document Control team, as well as support QMS procedural improvements and document workflow optimization.Summary of Key Respo...[show_more][last_updated.last_updated_1_day]
Job Title : Quality Assurance Specialist - US.Reports to : Head of Quality & Regulatory.The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, alon...[show_more][last_updated.last_updated_variable_days]
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life.
With over 21,000 employees worldwide across 23 locations in the US, UK an...[show_more][last_updated.last_updated_variable_days]
Job Title : Quality Assurance Associate.We are seeking a dedicated Quality Assurance Associate to support on-the-floor QA issues within our manufacturing suite.
You will play a crucial role in mitiga...[show_more][last_updated.last_updated_1_day]
Duration : 12+ months (possible extension).Client's testing team is responsible for ensuring the integrity of applications across the entire Client's agency which includes the Registry of Mo...[show_more][last_updated.last_updated_1_day]
For over 25 years, Abcam has been providing tools the scientific community needs to enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases, and metab...[show_more][last_updated.last_updated_variable_days]
Booming Consumers Products firm located outside of Boston seeks a Quality Assurance Manager to run the show! This is a growing firm with lots of opportunity to grow within the organization.Position...[show_more][last_updated.last_updated_variable_days]
This is a Finance position responsible for monitoring the quality of perishable products in the warehouse on an ongoing basis, inputting orders through data entry while performing extensive custome...[show_more][last_updated.last_updated_variable_days]
We're looking for motivated, engaged people to help make everyone's journeys better.This position is responsible for the oversight of all HACCP logs in the Hot Foods Production ensuring that the lo...[show_more][last_updated.last_updated_variable_days]
This position will be remote, but with a preference for candidates in Ohio, Missouri, Texas, or Louisiana.This is your chance to be part of an in-house Brands team of industry experts in the domain...[show_more][last_updated.last_updated_variable_days]
Job Title : Quality Assurance Specialist - US.Reports to : Head of Quality & Regulatory.The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, alon...[show_more][last_updated.last_updated_variable_days]
The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed.The QA Specialist will ha...[show_more][last_updated.last_updated_variable_days]
As part of the Commercial Engineering organization, you will be part of a fast-paced, entrepreneurial, energetic, and high performing team at the heart of the Thomson Reuters transformation to deve...[show_more][last_updated.last_updated_variable_days]
Job Description Specific Duties will include : .Creating and documenting manual test plans, test scenarios, test cases and test scripts.
Executing test cases and documenting test results.Helping with ...[show_more][last_updated.last_updated_variable_days]
SUMMARY - Quality Assurance Tester.The QA Analyst will design and develop test cases utilizing manual and automated methods.
The individual must be able to analyze and understand business and techni...[show_more][last_updated.last_updated_variable_days]
This job is with Encode, Inc a fully owned subsidiary of Lancesoft.Title : Quality Assurance Specialist Location : Lexington, MA Duration : 3 years Contract This is HYBRID job Responsibilities include...[show_more][last_updated.last_updated_variable_days]
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- [job_card.full_time]
[job_card.job_description]Bachelor's Degree is required (Biological sciences, Engineering or related degree); advanced degree is a plus. Minimum of 5 years related experience in the Pharmaceutical / Biopharmaceutical / Biotechnology industry. Ideally a minimum of 3 years of experience in leading a Quality function, preferably at the manager / supervisor level. Proven ability to effectively develop, communicate, and gain support for execution plans with team members from other functions. Management skills to grow and manage a high performing Quality organization. Demonstrated skills in project management and working with vendors and contractors. Background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs. Familiar with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections. Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program / project deliverables. Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives. Must be available to work in the evenings and weekends, as required. Position is in the United States (Irvine, CA or Cambridge, MA). Position may require up to 20% travel (or) occasional local travel.
Manager of Quality Assurance
The Manager of Quality Assurance is responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system which supports clinical development and regulatory approval of products. This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs.
Responsibilities include :
- Develop, implement, maintain and continually assess a quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.
- Execution of the processes related to the development of all quality assurance activities and quality management system.
- Administering policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system.
- Establishing and maintaining a document control system for procedures, work instructions and forms.
- Batch record review and disposition.
- Manage Deviation and Change Control programs.
- Assist with executing appropriate quality training for the team.
- Quality oversight of IT systems used to support Quality activities.
- Gather relevant information and author report related to Annual Product Reviews.
- Review of CMC sections for regulatory submissions.
- Assist during regulatory inspections.
- Conduct incident investigations and identify related Corrective and Preventive Action (CAPA) activities and processes.
- Performing internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities.
- Execute Vendor management program.
- Implement short-term and long-term strategies, goals, and objectives related to the quality assurance function and the quality management system.
- Review corrective actions to ensure consistency with the quality assurance function and the quality management system.
- Implement a continuous improvement plan for growing and maturing the quality assurance function and the quality management system.
- Performing periodic internal quality management system reviews and audits.
- Track key quality, compliance and performance indicators.
- Implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality assurance function and the quality management system.
- Analyzing performance of quality assurance function and quality management system activities and documented resolutions, identifying problem areas, and devising and delivering solutions to enhance quality control and prevent future issues.
- Represent quality assurance function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation.
- Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards / requirements and current with industry trends and best practices.
- Remove obstacles to move work forward and / or to get efforts back on track.
Skills, Education and Experience :
Availability :
Position Location and / or Territory and Travel :