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Qa specialist Jobs in Boston, MA

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Qa specialist • boston ma

Last updated: 19 hours ago
  • Promoted
QA Specialist II

QA Specialist II

GenezenLexington, MA, US
Full-time
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 f...Show moreLast updated: 13 days ago
  • Promoted
QA Manager

QA Manager

CD PROJEKT REDBoston, MA, US
Full-time
To create revolutionary, story-driven RPGs which go straight to the hearts of gamers — this is our mission.Want to dive deeper into our company’s culture? Explore our social media and c...Show moreLast updated: 30+ days ago
  • Promoted
Senior QA Engineer

Senior QA Engineer

First Help FinancialNeedham, MA, US
Full-time
First Help Financial (FHF) is a fast-growing and culturally diverse company in the U.We provide auto loans to the underserved and care for our customers and partners with exceptional service.Throug...Show moreLast updated: 30+ days ago
  • Promoted
Clinical QA Specialist

Clinical QA Specialist

ElucidBoston, MA, US
Full-time
We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved qual...Show moreLast updated: 30+ days ago
Home Health Coder / QA Specialist

Home Health Coder / QA Specialist

Tufts MedicineRemote, Massachusetts
Remote
Part-time
Under the guidance of the VP of Quality, Compliance and Risk, the Home Health Coder-QA Specialist provides guidance to other members of the clinical team on overall quality and completeness of clin...Show moreLast updated: 30+ days ago
MRI QA Specialist

MRI QA Specialist

Mass General BrighamBoston, Massachusetts, US
Medical, Dental & Vision insurance : .A hospital funded pension plus a 403(b) with company match.MBTA passes or parking options available for evening, night and weekend staff.Reporting to the MRI Qua...Show moreLast updated: 30+ days ago
CT QA Specialist, Research

CT QA Specialist, Research

Brigham and Women's HospitalMA-Boston-BWH Boston Main Campus
CT QA Specialist, Research-(3291660).The CT Research Specialist will facilitate the CT Research program, integrating research studies into CT daily clinical operations. This team member will be resp...Show moreLast updated: 30+ days ago
  • Promoted
QA Senior Specialist

QA Senior Specialist

cGxPServeBoston, Texas, USA
Full-time
Ensure distribution licenses (where required) accurately reflect the current organization vary license where necessary.Support recalls mock recalls and any other onmarket activity.Serve as QA asses...Show moreLast updated: 5 days ago
QA Specialist

QA Specialist

Katalyst HealthCares & Life SciencesWatertown, MA
Essential duties and responsibilities : .Developing, continuously improving, and implementing procedures related to Documentation Management. Assisting functional area management in driving timely com...Show moreLast updated: 30+ days ago
  • Promoted
Food Safety and QA Specialist

Food Safety and QA Specialist

Cooke Inc.Waltham, MA, United States
Full-time
Reporting to the Vice President of Food Safety & Quality Assurance for our subsidiary, Slade Gorton, the Regulatory and QA Specialist is responsible for ensuring all elements of product labeling ar...Show moreLast updated: 25 days ago
  • Promoted
  • New!
QUALITY ASSURANCE (QA) SPECIALIST - SECURITY CLEARANCE REQUIRED

QUALITY ASSURANCE (QA) SPECIALIST - SECURITY CLEARANCE REQUIRED

CACiBoston, MA, United States
$62,200.00–$130,600.00 yearly
Full-time
Quality Assurance (QA) Specialist.Job Category : Consulting Time Type : Full time Minimum Clearance Required to Start : Secret Employee Type : Regular Percentage of Travel Required : Up to 10% Type of T...Show moreLast updated: 19 hours ago
Training & QA Specialist - Patient Access

Training & QA Specialist - Patient Access

Newton-Wellesley HospitalNewton, MA, US
Full-time
Job Description - Training & QA Specialist - Patient Access (3309246).Training & QA Specialist - Patient Access-(3309246). Under the direction of the Patient Access Manager, the Training & QA Specia...Show moreLast updated: 30+ days ago
  • Promoted
Senior QA Engineer

Senior QA Engineer

ZipRecruiterBoston, MA, US
Full-time
This is a fully remote opportunity.Gradient AI is a leading provider of AI solutions for the Group Health and P&C insurance industries. Our solutions improve loss ratios and profitability by pre...Show moreLast updated: 13 days ago
  • Promoted
Senior QA Engineer

Senior QA Engineer

Verve IncCambridge, MA, US
Full-time
Verve is building a world-class team to commercialize wearable solutions that empower the way people move in the world.Our first product is a lightweight, connected wearable system that can be worn...Show moreLast updated: 30+ days ago
  • Promoted
QA Specialist

QA Specialist

PharmaronWoburn, MA, US
Full-time
Pharmaron are seeking a dedicated.At Pharmaron, we pride ourselves on fostering innovation and delivering quality in a cGxP-compliant bioanalytical environment. As a QA Specialist, you'll play a...Show moreLast updated: 30+ days ago
MRI QA Specialist

MRI QA Specialist

Massachusetts General HospitalBoston, MA, US
Reporting to the MRI Quality Assurance Manager, the MRI Quality Assurance specialist will assist with the MRI Quality Assurance program by collecting data, implementing new protocols, provides appr...Show moreLast updated: 30+ days ago
QA, Senior Specialist

QA, Senior Specialist

Katalyst Healthcares & Life SciencesBoston, MA
Full-time
Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary.Support recalls, mock recalls and any other on-market activity.Serve as QA as...Show moreLast updated: 6 days ago
  • Promoted
Quality Assurance (QA) Specialist - Security Clearance Required

Quality Assurance (QA) Specialist - Security Clearance Required

CACIBoston, Massachusetts
$62,200.00–$130,600.00 yearly
Full-time
Quality Assurance (QA) Specialist.Minimum Clearance Required to Start : Secret.Percentage of Travel Required : Up to 10%. Type of Travel : Continental US.Serves as a Quality Assurance (QA) Specialist w...Show moreLast updated: 2 days ago
  • Promoted
Supply Chain / Logistics, GDP Operational QA, Specialist / Sr. Specialist (Contract)

Supply Chain / Logistics, GDP Operational QA, Specialist / Sr. Specialist (Contract)

BioPharma Consulting JAD GroupBoston, MA, US
Full-time
The Quality Senior Specialist role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the USA in compliance with GDP and GMP requirements.The Quality ...Show moreLast updated: 30+ days ago
QA Specialist II

QA Specialist II

GenezenLexington, MA, US
13 days ago
Job type
  • Full-time
Job description

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

  • Adaptability required as work schedule may change based on business needs.
  • Criminal background check required.
  • Other duties as assigned
  • 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

  • Regularly sit for long periods of time.
  • Movement

  • Occasionally required to walk
  • Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail
  • 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

  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life / personal accident insurance
  • Voluntary disability, universal life / personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance
  • ADDITIONAL DETAILS

  • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
  • 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.