Current jobs related to Senior Specialist, Quality GMP - Boston, Massachusetts - Entrada Therapeutics
-
Senior Quality Assurance Specialist
5 days ago
Boston, Massachusetts, United States Vertex Full timeJob Title: Senior Specialist GMP Operational QualityJob Summary:We are seeking a highly skilled Senior Specialist GMP Operational Quality to join our team at Vertex. This role will provide QA support of manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs.Key Responsibilities:Review master...
-
Senior Quality Assurance Specialist
2 weeks ago
Boston, Massachusetts, United States Vertex Full timeJob Summary:The Senior Quality Assurance Specialist will provide quality support to Vertex's manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems...
-
Senior Quality Assurance Specialist
2 weeks ago
Boston, Massachusetts, United States Vertex Full timeJob Summary:The Senior Quality Assurance Specialist will provide critical support to Vertex's manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems...
-
Quality Assurance Specialist
1 day ago
Boston, Massachusetts, United States Arcaea Full time{"h1": "Quality Assurance Specialist at Arcaea", "p": "Arcaea is a biology-first beauty company that is revolutionizing the beauty and personal care industry with pioneering ingredients, products, and stories accessible uniquely through biology. We are seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing...
-
Quality Assurance Senior Specialist
3 days ago
Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Quality Assurance Sr. SpecialistWe are seeking a highly skilled Quality Assurance Sr. Specialist to join our team at Moderna Inc.About the Role:This is a challenging and rewarding opportunity for a quality professional to provide on-the-floor quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues...
-
Senior Quality Assurance Manager
2 days ago
Boston, Massachusetts, United States Engtal Full timeKey Responsibilities:As a Senior Quality Engineer at Engtal, you will lead the development and implementation of robust quality systems for biotech products. This includes ensuring full compliance with FDA, ISO 9001, ISO 13485, and GMP regulations.You will investigate non-conformances and manage CAPA processes, performing root cause analysis and...
-
Quality Assurance Specialist
3 weeks ago
Boston, Massachusetts, United States Verista Full timeJob Description**About Verista**Verista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with the world's most recognizable brands to empower growth and innovation within the scientific community.**Job Summary**We are seeking a highly skilled Quality Assurance Specialist to join our...
-
Quality Assurance Specialist
3 weeks ago
Boston, Massachusetts, United States Verista Full timeJob Description**About Verista**Verista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with the world's most recognizable brands to empower growth and innovation within the scientific community.**Job Summary**We are seeking a highly skilled Quality Assurance Specialist to join our...
-
Senior Registered Nurse
3 days ago
Boston, Massachusetts, United States Mass General Brigham Full timeJob Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled Senior Registered Nurse to join our Quality Assurance team. As a Senior Registered Nurse - Quality Assurance Specialist, you will play a critical role in ensuring the highest quality of care for our patients.Job Summary:The Senior Registered...
-
Quality Assurance Specialist
2 weeks ago
Boston, Massachusetts, United States LSG Sky Chefs Full timeAbout UsLSG Sky Chefs is a leading provider of airline catering and hospitality services, renowned for its commitment to excellence and innovation in the industry. As a trusted partner to airlines and their passengers, we strive to deliver exceptional culinary experiences and outstanding service across North and Latin America.Job SummaryWe are seeking a...
-
Director of Quality Assurance
2 weeks ago
Boston, Massachusetts, United States AVEO Oncology Full timeJob Description**Job Summary:**The Senior Director of Quality Assurance at AVEO Oncology is responsible for leading the development and implementation of quality strategies and objectives across the organization. This role requires a high level of expertise in quality operations, regulatory compliance, and supplier quality management.Key...
-
Quality Assurance Specialist
1 day ago
Boston, Massachusetts, United States LSG Sky Chefs Full timeLSG Sky Chefs is a leading airline catering and hospitality provider, renowned for its exceptional quality and innovative approach. As a Quality Assurance Coordinator, you will play a vital role in maintaining our Global Quality System, ensuring compliance with customer, FDA, USDA, and HACCP plans. Your primary responsibility will be to monitor and maintain...
-
Senior IT Quality Assurance Specialist
1 week ago
Boston, Massachusetts, United States Berkshire Hathaway Specialty Insurance Full timeJob Opportunity:Berkshire Hathaway Specialty Insurance is seeking an experienced IT Quality Assurance Professional to join our Boston-based Information Technology Team.We are creating and supporting multiple complex applications within BHSI and are seeking candidates with Enterprise Application IT experience. An ideal candidate will have hands-on experience...
-
Manufacturing Operations Specialist
2 days ago
Boston, Massachusetts, United States Insight Global Full timeJob Title: Manufacturing Operations SpecialistLocation: Boston, MAPay Rate: $35-42/hourDuration: 9 month C2HJob Description:A leading biotechnology company in the Greater Boston area is seeking a skilled Manufacturing Operations Specialist to join their Cell Manufacturing team. As a key member of the team, you will be responsible for supporting the clinical...
-
Clinical Specialist
4 hours ago
Boston, Massachusetts, United States Mass Inc Full timeAbout the RoleThe Office of the Child Advocate (OCA) is seeking a highly skilled Clinical Specialist to join its Quality Assurance Team. As a key member of the team, you will play a critical role in ensuring the quality of state services provided to children and families.Key ResponsibilitiesPerform ombudsperson functions on the OCA Complaint Line, responding...
-
Senior Infrastructure Specialist
6 days ago
Boston, Massachusetts, United States Ampcus Full timeJob Title: Senior Infrastructure SpecialistAmpcus Inc. is a leading provider of technology and business consulting services. We are seeking a highly motivated and experienced Senior Infrastructure Specialist to join our team.Job Summary:The Senior Infrastructure Specialist will be responsible for administering, enhancing, and resolving issues in our...
-
Quality Control Analyst
3 weeks ago
Boston, Massachusetts, United States Arcaea Full timePosition OverviewArcaea is a pioneering beauty enterprise focused on leveraging biological innovations to create a unique set of ingredients for the beauty and personal care sector. Our mission is to develop groundbreaking ingredients, products, and narratives that are distinctly rooted in biology.We are on a quest to establish a revolutionary ingredient...
-
Quality Systems Manager
3 weeks ago
Boston, Massachusetts, United States PepGen Full timeJob OverviewPosition Title: Manager, Quality SystemsRole SummaryThe Manager of Quality Systems is responsible for the ongoing development and oversight of quality management frameworks that support clinical trial operations at PepGen. Key responsibilities include the formulation and upkeep of supplier management initiatives, which encompass qualification...
-
Quality Systems Manager
4 weeks ago
Boston, Massachusetts, United States PepGen Full timeJob OverviewPosition Title: Manager, Quality SystemsRole SummaryThe Manager of Quality Systems is responsible for the ongoing enhancement and management of quality assurance frameworks that support clinical trial operations at PepGen. Key duties involve the development and upkeep of supplier management protocols, which encompass qualification evaluations,...
-
Quality Systems Manager
4 weeks ago
Boston, Massachusetts, United States PepGen Full timeJob OverviewManager, Quality SystemsPosition OverviewThe Manager of Quality Systems is responsible for the enhancement and upkeep of the quality management frameworks that support clinical trial operations at PepGen. Key responsibilities include the formulation and management of supplier oversight programs, which encompass qualification evaluations, audits,...
Senior Specialist, Quality GMP
4 months ago
What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.
Our Endosomal Escape Vehicle (EEVTM)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.
Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.
We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.
The Perfect Addition to Our Team
You are analytical and detail oriented. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly in order to provide robust and timely solutions. You are dependable and accountable for your work. You are an excellent team player and relationship builder.
The Opportunity
The Sr. QA Specialist will be responsible for supporting GMP QA processes, including master and executed batch record review and disposition of drug substances and drug products (including package and labeling). The positions is also responsible for owning and supporting deviations, change control, and CAPA's. This role will contribute to development of the internal Quality Management System (QMS) and support other internal QA functions including training, documentatio0n, This role is based in Boston, MA and reports directly to the Director of GMP QA.
Responsibilities
Review in-process, release, and stability data.
Disposition lots from intermediates through finished drug product.
Supports internal and external deviations, change control, and CAPA.
Supports Vendor Management Program, including management of vendor audit activities and the Approved Supplier List.
Writes and implements changes to Standard Operating Procedures.
Coordinates and reviews change control activities to drive change control records to closure.
Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records.
Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Policies.
Leads and supports understanding and adoption of risk-based approaches and decision making.
Serve as Quality resource, representing QA on teams in support of assignments.
Interacts on cross-functional teams including manufacturing and QC.
Supports all GxP functions as needed.
The Necessities
At Entrada, our passion for science, our devotion to patients and our values drives our behavior:
Humanity - We genuinely care about patients and about one another.
Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
Creativity - We are creative problem solvers.
Collaboration - We are more than the sum of our parts.
Curiosity - We have a growth mindset and push conventional thought and theory.
To thrive on our team, you will need to come with:
Experience supporting GMP and CMC functions from QA perspective is required.
Strong attention to detail and ability to communicate and collaborate with stakeholders outside of Quality.
Authoring and reviewing SOP's.
Based in the Boston area with ability to come into the office 3 days.
Method validation, stability, and other QC support functions are nice to have.
The Perks
By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
Third Party Staffing Agencies
Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy Statement
Entrada Therapeutics, Inc. (the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.
