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Qa specialist • boston ma
- Promoted
QA Specialist II
GenezenLexington, MA, US- Promoted
QA Manager
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Senior QA Engineer
First Help FinancialNeedham, MA, US- Promoted
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Mass General BrighamBoston, Massachusetts, USCT QA Specialist, Research
Brigham and Women's HospitalMA-Boston-BWH Boston Main Campus- Promoted
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Katalyst HealthCares & Life SciencesWatertown, MA- Promoted
Food Safety and QA Specialist
Cooke Inc.Waltham, MA, United States- Promoted
- New!
QUALITY ASSURANCE (QA) SPECIALIST - SECURITY CLEARANCE REQUIRED
CACiBoston, MA, United StatesTraining & QA Specialist - Patient Access
Newton-Wellesley HospitalNewton, MA, US- Promoted
Senior QA Engineer
ZipRecruiterBoston, MA, US- Promoted
Senior QA Engineer
Verve IncCambridge, MA, US- Promoted
QA Specialist
PharmaronWoburn, MA, USMRI QA Specialist
Massachusetts General HospitalBoston, MA, USQA, Senior Specialist
Katalyst Healthcares & Life SciencesBoston, MA- Promoted
Quality Assurance (QA) Specialist - Security Clearance Required
CACIBoston, Massachusetts- Promoted
Supply Chain / Logistics, GDP Operational QA, Specialist / Sr. Specialist (Contract)
BioPharma Consulting JAD GroupBoston, MA, USQA Specialist II
GenezenLexington, MA, US- Full-time
Job Description
Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The Quality Assurance Specialist II supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, change controls, batch record review, batch disposition, and data integrity in support of biologics / gene therapy manufacturing production.
ESSENTIAL JOB FUNCTIONS
- Oversee and provide compliance guidance during on-the-floor manufacturing activities.
- Work alongside manufacturing teams to ensure current and best practices are implemented.
- Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
- Review and approve executed batch records, solution lot records, and logbooks.
- Participate batch disposition activities.
- QA support of drug product aseptic fill operations and vial visual inspections.
- Assist in deviation investigations.
- Support internal and external audits and inspections.
- Support the continuous improvement.
- Other duties as assigned.
SPECIAL JOB REQUIREMENTS
KNOWLEDGE, SKILLS AND EXPERIENCE
3-5 years of relevant GMP experience in pharma / biotech company, working within a quality system and regulated GMP environment
Essential
Experience working in a cGMP manufacturing environment
Essential
Well versed in cGMP / ICH / FDA / EU regulations and guidelines
Essential
Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)
Essential
Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically
Essential
Strong written and verbal communication skills to interact with cross function teams
Essential
Strong organizational skill
Essential
High level of attention to detail
EssentialGood problem-solving skillsEssential
Capable of working with minimal supervision
Essential
Ability to work well with diverse groups
Essential
Ability to multi-task in a fast-paced environment with challenging timelines
Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands :
Work Environment
Movement
Communication
GENEZEN'S CURES VALUE-BASED COMPETENCIES
C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
ADDITIONAL DETAILS
Genezen has operates two locations : one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.