Quality Assurance SpecialistStratus Therapeutics • Watertown, MA, US
Quality Assurance Specialist
Stratus Therapeutics • Watertown, MA, US
30+ days ago
Job type
- Full-time
- Quick Apply
Job descriptionWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. The Quality Assurance (QA) Specialist will play a key role in maintaining our Quality Management System (QMS), supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline. Perform review and approval of GMP documentation including batch records, quality control test data, technical reports to ensure compliance with GMP and regulatory standards Manage the issuance and / or revision of controlled GMP documentation including production batch records, logbooks, labels and forms ensuring compliance with document control procedures Maintain a document control system, ensuring that all documents are properly tracked, version-controlled, and readily available to authorized personnel Conduct quality investigations of non-conformances, deviations, and CAPAs, support root cause analysis and follow-up Collaborate with Manufacturing, Quality Control, and Process Development teams to ensure that quality is built into all processes Review and approve SOPs, protocols, validation documents, and change controls Conduct internal audits and routine QA walkthroughs in GMP manufacturing areas Support supplier qualification program including material release Support training and onboarding of personnel on QA and GMP topics Ensure documentation is maintained accurately and timely in compliance with GDP (Good Documentation Practices) and support the document archival process Maintain an understanding of regulatory trends and guidelines relevant to advanced therapy medicinal products (ATMPs) Support audits and inspections by regulatory agencies, clients, and internal stakeholders Qualifications include : Bachelor’s degree in scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering or related field) is required 3+ years of experience in Quality Assurance within a GMP-regulated environment, preferably in cell / gene therapy or biologics industry is required Strong knowledge of FDA, EMA, and ICH regulations Excellent attention to detail and organizational skills Strong verbal and written communication skills Ability to work in a fast-paced, dynamic environment and collaborate effectively across teams Must be able to laugh and contribute to a positive work culture AAP / EEO Statement Stratus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and / or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. Powered by JazzHR
Position Title :
- Quality Assurance Specialist Reports to : Associate Director, Quality Assurance Status : Regular, Full-Time, Exempt Location : Watertown, MA (Onsite) Company Summary : Stratus Therapeutics is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.
- Stratus Therapeutics is committed to advancing science and enhancing the health and well-being of patients.
- This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.
Position Summary :
Specific responsibilities include, but are not limited to :
Create a job alert for this search
Quality Assurance Specialist • Watertown, MA, US
Related jobs
Become a vital part of our commitment to quality.As a Quality Assurance Specialist I, you will help oversee site Quality Assurance activities and ensure our Quality Management System operates effec...Show more
Associate Quality Systems Specialist.Boeing Defense Space & Security (BDS).Site Supplier Quality Team located in.This position will be supporting supplier Corrective Actions data analytics and ...Show more
The Quality Specialist primary responsibilities include manufacturing process work instruction and manufacturing equipment calibration procedure preparation, training and performance oversite, and ...Show more
About Shields Advanced Therapies.Shields Advanced Therapies partners with health systems to accelerate advanced therapy access and operations, ensuring lifechanging breakthroughs reach more patient...Show more
Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more 
To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values.
These values - integrity, patient-centered, respect, account...Show more
To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values.
These values - integrity, patient-centered, respect, account...Show more
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform.
With only five minutes of wear-time on the skin, the self-applied...Show more
Candidate selected will work at the Chelmsford MA facility for badging and training (2-3 weeks).Once training is completed, contractor will then work full time at the below location : .Collaborates w...Show more
The Quality Assurance (QA) Specialist is responsible for analyzing the efficiency and effectiveness of individual case analysts.
The QA Specialist reviews cases, interactions, and evaluates them for...Show more Quality Systems Specialist (Material Review Records).Boeing Commercial Airplanes (BCA).Experienced or Senior Quality Systems Specialist.
Level 3 or Level 4) to join the.Everett Washington; Renton Wa...Show more 
Position Title : Quality Control Technician.Work Location : Worcester, MA 01605.Assignment Duration : 6 Months (Possible Extension).
Work Arrangement : Onsite - Requires standing for most of the shift a...Show more
We are urgently looking for people interested in taking online surveys for Fortune 500 brands.If you are a self-starter, looking for flexible hours throughout the week, this may be for you! Earn up...Show more
We are seeking a skilled QualityAssuranceAnalyst with automation testing expertise to join our quality assurance team.In this role, you will be responsible for ensuring the quality and reliability ...Show more
Join a global community of talented professionals to shape the future of AI.Earn up to $15 USD / hr and additional rewards based on quality of submission.
Outlier is committed to improving the intelli...Show more
Founded on a commitment to relentless, continuous operational improvement and extraordinary customer service, we at Pursuit Aerospace pride ourselves on competitive cost structures, exceptional on-...Show more
Job Title : Quality Control Microbiology Analyst II.Duration : 6 Months+ (Possibilities of Extension).The Quality Control Microbiology Analyst II plays a role in supporting the department's efforts t...Show more
Quality Assurance Specialist (QAS) - Pharmaceutical CGMP
SOFIE • Haverhill, MA, US
Full-time
Last updated: 30+ days ago • Promoted
Associate Quality Systems Specialist
Boeing • Everett, Massachusetts, USA
Full-time +2
Last updated: 1 day ago • Promoted
Quality Specialist
Electroswitch • Weymouth, Massachusetts, United States
Full-time
Quick Apply
Last updated: 30+ days ago
Accreditation & Quality Specialist
Shields Advanced Therapies • Boston, MA, USA
Full-time
Quick Apply
Last updated: 30+ days ago
Remote Content QA Reviewer
Outlier • Worcester, MA, United States
Remote
Full-time
Last updated: 9 days ago • Promoted
Remote Text Quality Evaluator
Outlier • Pawtucket, RI, United States
Remote
Full-time
Last updated: 9 days ago • Promoted
CRNA Quality Improvement Specialist
Yale New Haven Health • Valley Falls, RI, United States
Full-time
Last updated: 16 days ago • Promoted
CRNA Quality Improvement Specialist
Yale New Haven Health • Cumberland, Rhode Island, United States
Permanent
Last updated: 1 day ago • Promoted
Quality System Specialist / Senior Quality System Specialist
Vaxess Technologies • Woburn, MA, United States
Full-time
Last updated: 6 days ago • Promoted
Quality Assurance Engineer
Butler Aerospace and Defense • Nashua, NH, US
Full-time +1
Last updated: 30+ days ago • Promoted
Bilingual Customer Quality Specialist
Boston Staffing • Boston, MA, US
Full-time
Last updated: 20 days ago • Promoted
Quality Systems Specialist (Material Review Records)
Boeing • Everett, Massachusetts, USA
Full-time
Last updated: 5 days ago • Promoted
Quality Control Technician
Spectraforce Technologies • Worcester, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Freelance Product Feedback Specialist (Hiring Immediately)
Earn Haus • Northbridge, Massachusetts, US
Full-time +2
Last updated: 30+ days ago • Promoted
Senior Quality Assurance Analyst
Kelmar • Wakefield, MA, United States
Full-time
Last updated: 30+ days ago • Promoted
Content Quality Specialist - Remote
Scale AI • Boston, Massachusetts, United States
Remote
Full-time
Last updated: 10 hours ago • Promoted • New!
Quality Inspector
Pursuit Aerospace • Newburyport, MA, United States
Full-time
Last updated: 16 days ago • Promoted
Quality Control Microbiology Analyst II
Careers Integrated Resources Inc • Norton, MA, US
Full-time
Last updated: 25 days ago • Promoted