79 quality-assurance-control jobs found in Boston, MA

Job Description The Sr Manager- Quality and Risk Management in R&D Quality is part of the  Quality Assurance Organization, and is responsible for performing GCP quality assurance oversight and management activities of clinical trial operations to ensure trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols, policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities. Experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics is advantageous. This individual is responsible for adhering to the Vertex quality standards as set forth in the Quality Management System (QMS)....

GMP Quality Auditor – Boston (Remote)(EST or CST candidates) 6 months, possibility to extend  Pay Rate Range: $45-$50/hr Details: Bachelors degree in related field Looking for someone with 3-5 years’ experience Must have solid experience in GMP Pharmaceutical field – Quality Must have experience as an external auditor for contract manufacturers or venders and have experience auditing other companies. No financial auditors. Bachelor's degree in a relevant field is required and typically requires 4 years of experience or the equivalent combination of education and experience Experience as GxP generalist or in applicable specialty area such as manufacturing, distribution, laboratory, or clinical practices Coordinates the development of, maintains, supports activities for, and executes audit plans Provides input for audits that are outsourced Conducts audits of GMPs or GDPs for CxOs Temporary Quality Auditor Temporary Quality Auditor...

Duties: ClientPharmaceuticals is seeking a Full Time Manager, Quality Systems, to join the Central Quality Systems and Compliance team. This role will interface globally with users across Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control. Principal Responsibilities Use deep process knowledge and experience to assist business partners with the creation, review, approval, closure and monitoring of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements. Collaborate with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS. Proactively identify risks, issues and best practices within the QMS. On-time completion of assigned projects. Establish new and improve existing forums for performance...

The Manager/Senior Manager, Quality Compliance position is responsible for managing the internal and external audit program, and maintaining the master audit schedule and the approved vendor list. The position leads and performs GMP audits, assessments of contract manufacturers, suppliers and GMP service providers. Client Details This company is dedicated to create and deliver transformative medicines for people living with psychiatric and neurological conditions. Description Manage the internal and external audit program. Lead or participate in GMP audits and assessments of contract manufacturers, suppliers and GMP service providers involved in the manufacture, packaging, testing and distribution of products in clinical and commercial phases. Assess if the auditee is executing operations in compliance with cGMP regulatory requirements, Karuna Quality Standards and Quality Agreement requirements and their own SOPs. Interpret regulatory and business challenges and best...

The Manager/Senior Manager, Quality Compliance position is responsible for managing the internal and external audit program, and maintaining the master audit schedule and the approved vendors. Client Details This company creates and delivers transformative medicines for people living with psychiatric and neurological conditions. Description Manage the internal and external audit program. Lead or participate in GMP audits and assessments of contract manufacturers, suppliers and GMP service providers involved in the manufacture, packaging, testing and distribution of products in clinical and commercial phases. Assess if the auditee is executing operations in compliance with cGMP regulatory requirements, Quality Standards and Quality Agreement requirements and their own SOPs. Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to cGMP compliance issues, and recommend required improvements or solutions. Profile...

RESPONSIBILITIES: Kforce's client in Boston, MA has a newly created role at growing national company to create the Data Quality Lead function. Join a fast-evolving BI team. This is an individual contributor role. This is a fully remote, direct hire position. Summary: The Data Quality Lead will focus on data sources, from Salesforce and other systems, with Gigabytes of data. The candidate will work closely with BI Engineers, Analysts, and Tableau developers. This is a proactive role with company-wide responsibilities. They will look at all BI assets in the organization, also data governance and stewardship. Job Requirements: REQUIREMENTS: Technical degree Extensive SQL development experience, data pipelines, BI dashboards, repots, and a passion for data quality Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual...

TITLE: Quality Specialist –Quality Standards, Training and Improvement  AR EA: Quality Systems – GPOC GENERAL POSITION SUMMARY: The Quality Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision.  The Specialist applies technical proficiency and attention to detail in “troubleshooting,” as well as the ability to interpret and execute project plans, and lead initiatives with minimal guidance. GENERAL RESPONSIBILITIES AND REQUIRED SKILLS: In addition to the attributes of a Quality Specialist: Presents a solid understanding of quality assurance concepts and practices Demonstrates emerging knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts Exercises independent judgment to optimize some commonplace compliance procedures Displays an emerging ability to manage client expectations Displays effective...

The Cell Manufacturing Quality Specialist I participates in monitoring operations and quality improvement initiatives by gathering quality data and reviewing metrics to assist in ensuring that systems are safe, effective, appropriate, compliant, current and adhered to by CMCF staff.  The Cell Manufacturing Quality Specialist I builds understanding of quality management practices to the monitoring and improvement of CMCF operations. This position is a fully onsite position in the Longwood Medical Area. The Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) assists DF/HCC members in developing new cell-based therapies for patients with cancer who are enrolled in novel therapeutic clinical research protocols. It also supports clinical research studies designed to evaluate the safety and efficacy of these novel treatments.  Please visit  https://cmcf.dana-farber.org Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life...

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. *Description* * Represent QA and provide QA guidance for project/study team with participation in providing GCP compliance input and guidance to Clinical Operations * Interface with relevant stakeholders, including Regulatory, Clinical and Development sub-team * Develop, implement and execute the audit strategy and plan for clinical programs * Conduct external GCP audits * Participates in the development of the GCP Quality Management Systems * Implement internal GCP compliance audit and inspection readiness strategy * Provides GCP training and Mock Inspection...

* Maintain applicable quality systems, environmental, and FDA requirements/certifications. * Work with team members and support manufacturing/operations to solve quality, cost and schedule issues. * Proficient in full and proper Geometric Dimensioning & Tolerancing (GD&T) application, and blueprint reading. * Determine/improve inspection methods/instructions and incorporate them into the manufacturing processes and Inspection Plans. * Prepare and maintain FMEA's, control plans, quality plans, and PPAP. * Coordinate process validations and reduce dependence on inspection. * Generate applicable quality metric reports; cost of quality, management by facts. * Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses. * Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard...

Now hiring a Quality Assurance Engineer in Chelsea!Trillium Technical is now seeking a Quality Assurance Engineer for long-term work in Chelsea, MA! Our Client is rewriting its Underground Storage Tank Program (UST) web site from the ground up. The legacy system is built on Asp.Net Webforms. The new system will be .Net Core 5.0 on MVC with Entity framework over Oracle as the data layer. The UST website is used to allow business owners and the delegates to work directly with the Underground Storage Tank Program administration. The system allows them to register their businesses, file claims for underground tank incidents (e.g., a leakage, etc.), file for Certificates of Completion (COC) on installation and restoration work and many other activities. The system allows administrators to manage the COC, Claims and other associated processes. This position will be responsible for all SQA activities on major features of the UST web application. If interested, please apply today!• At...

Sr. Manager/Associate Director, Pharmacovigilance Quality Local to Massachusetts ( Remote with 1 day a month on site )  Contract to Perm  Reporting to the Sr. Director of PVQA Quality, R&D Quality (RDQ), the Senior Manager/ Associate Director, PV Quality, will be a key contributor in growing and shaping ***'s global R&D Quality Program (GCP/GLP/GVP/CSV). Primarily focusing on PV Quality, the Associate Director will assist and contribute to building RDQ's presence globally, aid in the establishment and execution of PV Quality, support ***'s R&D activities both locally and globally. Support Health Authorities Inspections (e.g., MHRA, EMA etc.) and provide oversight of the Pharmacovigilance Quality audit program (e.g., Affiliate/ Vendor/Process Audits, etc.) partnering with RDQ Program Leads. This role will also support other R&D Quality GxP disciplines (GCP, GLP, and CSV) including proactive quality support, identification and conduct of audits, support of Health...

Now hiring a Quality Assurance Engineer in Cambridge!Trillium Technical is now seeking a Quality Assurance Engineer in Cambridge! QA Engineer identifies, analyzes, and reports defects with full evidence, such as functionality errors, inconsistencies in software program functions, file outputs, user interface forms, content, and system usability issues. The QA Engineer will participate as part of a team in all phases of development for existing and new services. Will troubleshoot and proactively resolve software issues. Ensure compliance with standards for security, privacy, and accessibility. Collaborate with other members of the team, including the software architect, project managers, business analysts, other QA team members and testers. Work with developers, systems and database experts to ensure successful integration with existing systems and services. Uses automated test scripting and execution tools. Reporting to the Quality Assurance Manager, the Quality Assurance Analyst...

Our client in Quincy, MA has an onsite role for a Data Quality Technical Lead. Role includes technical management of a small team of data quality developers in designing and developing effective data quality frameworks to ensure accuracy and legitimacy of quality data, The work will include design, analysis, data management, programming, and testing of moderate to complex data extraction routines, report development, and web application development. Our systems are table-driven, requiring an ability to think and code on an abstract level. Furthermore, there are multiple layers of code, including SQL, Java, HTML/JavaScript, Cognos and Excel. Job Duties: Research, design, develop, and implement AI solutions for data quality including data mastering Provide technical leadership to a data quality team Work with stakeholders to understand data quality issues. Develop long-term technical solutions to address data quality issues Present and explain data quality standards...

Quality Manager Needed For Innovative and Growing Medical Device Engineering Company This Jobot Job is hosted by: Billy Surch Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers. Why join us? Competitive base salary and overall compensation package Full benefits: Medical, Dental, Vision Generous PTO, vacation, sick, and holidays Life Insurance coverage 401 (K) with generous company match Job Details Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. Lead the organization’s Quality staff to ensure alignment to operations, support Lean efforts and drive quality improvement for services/processes. Work closely with...

Job Description Summary Managers who have responsibility across multiple job families (eg. Quality Assurance & Quality Control). Have direct reports (or dotted line reports). Should be used for regional or product line scope. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market Job Description The Lead Quality Management Specialist is responsible for product quality review associated with the manufacturing process. We are looking for a seasoned individual with a deep understanding of concepts, approaches and methodology used. This individual should also have a deep level of expertise in the technological field including the quality assurance of products, services and manufacturing processes. You will be supporting TFTJ Engine Programs and NPI development. Roles and Responsibilities Serve as focal for the overall quality of the conformance in...

Job Description Summary Managers who have responsibility across multiple job families (eg. Quality Assurance & Quality Control). Have direct reports (or dotted line reports). Should be used for regional or product line scope. Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. Job Description   Job Description Summary The Lead Quality Management Specialist is responsible for product quality review associated with customer contractual and GE quality system requirements. We are looking for a seasoned individual with a deep understanding of concepts, approaches and methodology used to assure customer satisfaction and compliance to quality system. This individual should also have a level of expertise in...

Provide Quality Engineering support for NPD, Manufacturing, and other Supply Chain functions throughout all phases of Design Controls. This is a collaborative position working closely with R&D, Manufacturing, Sales & Marketing, and others to ensure a constant state of control and compliance with QMS, and FDA QSR requirements. Client Details Our client spent many hours shadowing physicians to learn about the struggles of vascular access during procedures. After trial and error, our client developed and perfected their patent approved, unique-to-market catheter offering the least intrusive option for vascular visual access. With two products on the market and more on the way, our client is growing and looking to make additions to the team to match this financial growth. Description The Senior Quality Engineer will: Provide Quality Engineering support for New Product Development, Manufacturing, and other Supply Chain functions throughout all phases of Design...

Job Summary   The Boyd Quality Engineer is responsible for ensuring that Boyd products exceed the requirements and expectations of our customers. This individual will assume full responsibility for all aspects of product quality and serve as Boyd’s representative for all customer issues related to the product. The Quality Engineer will take the actions necessary to improve product quality by identifying and addressing product non conformances. Emphasis is on proactively managing customer satisfaction by delivery the highest quality thermal products in the industry.   Key Duties   Serve as the Boyd lead for product quality and reliability issues for Boyd’s line of System Cooling Products. Establish and implement processes for addressing and resolving customer product quality issues in a timely manner. Define quality requirements at the shop floor level. Work with shop floor management to identify failure modes and drive improvement....

Quality Engineering Architect Position Description Join us in building one of the largest independent technology and business services firms in the world. CGI, founded in 1976 on the concept of crafting an organization passionate about delivering results and exceeding client expectations. At CGI-Burlington, our success comes from the talent and dedication of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. We are hiring highly motivated Quality Engineering Architect to work with a top Retail company who can define help drive Quality Engineering transformation and contribute to strategies on new initiatives like test data management, tool migration, automation testing, CI / CD build out, analysis, and application development. The outcome of this role will elevate the efficiency and quality of delivery to customers. Your future duties and responsibilities • Thought leadership -...