-
Manager, Quality Engineering
2 weeks ago
AbelZeta Inc Rockville, United StatesJob Description · Job DescriptionAbelZeta is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global resea ...
-
Quality Assurance Engineer
4 days ago
GAP Solutions, Inc. (GAPSI) Rockville, United StatesTHIS POSITION IS FULLY REMOTE Position Objective: We are seeking a versatile candidate who can conduct quality assurance testing for a government customer's flagship application and multiple supporting applications. Candidate will be responsible for creating test plans, developin ...
-
Project Quality Assurance Engineer
2 days ago
X Energy, LLC Rockville, United States· Position Description: · X Energy, LLC is seeking a Project Quality Assurance Engineer responsible for performing Quality Assurance services in support of X-energy's reactor development project, including documenting, implementing, and maintaining United States Commercial Nucl ...
-
Quality Engineer
3 days ago
EchoStar Germantown, United States Full timeToday, our brands include EchoStar, Hughes, DISH TV, Sling TV, Boost Infinite, Boost Mobile, DISH Wireless, OnTech and GenMobile. · EchoStar has an exciting opportunity for Quality Engineer in our Hughes Network Systems division. This position is located in our Germantown, MD ...
-
Quality Engineer
9 hours ago
EchoStar Germantown, United StatesPartner with business teams to consult and define business performance KPIs. Analyze KPIs and customer feedback from customer satisfaction surveys to identify process improvement opportunities. Develop and publish performance reports using data vis Quality Engineer, Industrial En ...
-
Associate Director of Quality Engineering
1 week ago
AstraZeneca Gaithersburg, United StatesAre you ready to foster an attitude of excellence? Join AstraZeneca's Operations team as the Associate Director of Quality Engineering. In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the ...
-
Quality Engineer
6 days ago
Lockheed Martin Washington, United StatesJob Description · Applies quality principles in the areas of: design, incoming material, production control, product evaluation, program performance, reliability, inventory control, and/or research and development as they apply to product or process quality for make and/or buy p ...
-
Associate Director of Quality Engineering
2 weeks ago
AstraZeneca, plc Rockville, United StatesAre you ready to foster an attitude of excellence? Join AstraZeneca's Operations team as the Associate Director of Quality Engineering. In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Quality Engineer, Director, As ...
-
Associate Director of Quality Engineering
1 week ago
National Black MBA Association Rockville, United StatesAre you ready to foster an attitude of excellence? Join AstraZeneca's Operations team as the Associate Director of Quality Engineering. In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the ...
-
Quality Engineer
2 weeks ago
QinetiQ Lorton, United StatesCompany Overview · We are a world-class team of professionals who deliver next generation technology and products in robotic and autonomous platforms, ground, soldier, and maritime systems in 50+ locations world-wide. Much of our work contributes to innovative research in the fie ...
-
Electrical engineer in quality assurance
1 week ago
Crimson Technologies Rockville, United StatesRockville Electrical Engineer in Quality Assurance (m/f/d) · With room for your own ideas, modern working methods, a respectful environment, and a sustainable company culture, we are currently seeking an Electrical Engineer in Quality Assurance (m/f/d) to join our team at the ear ...
-
Senior Quality Engineer
2 weeks ago
ZoomInfo Technologies LLC Bethesda, United StatesJob Description · Job DescriptionAt ZoomInfo, we encourage creativity, value innovation, demand teamwork, expect accountability and cherish results. We value your take charge, take initiative, get stuff done attitude and will help you unlock your growth potential. One great choic ...
-
Quality Engineer
2 days ago
Bechtel Corporation Reston, United States**Requisition ID: 277003** · + **Relocation Authorized: National - Family** · + **Telework Type: Full-Time Office/Project** · + **Work Location: Reston, VA** · # Extraordinary teams building inspiring projects: · Since 1898, we have helped customers complete more than 25,000 ...
-
Quality Engineer
3 weeks ago
Progress Solutions Arlington, United StatesPosition: Quality Engineer (Experience in Megatronics) · Location: Arlington, TX (ON-SITE) · Job Type: (Full-Time) · Relocation Assistance: NO · Joining Bonus: NO · Appliances, Electrical, and Electronics Manufacturing · About the job · Primary Function: · • Under the direction o ...
-
Quality Engineer
1 week ago
Progress Solutions Inc Arlington, United StatesPosition: Quality Engineer (Experience in Megatronics) · Location: Arlington, TX (ON-SITE) · Job Type: (Full-Time) · Relocation Assistance: NO · Joining Bonus: NO · Appliances, Electrical, and Electronics Manufacturing · About the job · Primary Function: · Under the direction of ...
-
Quality Engineer
3 weeks ago
Pro-Tech Staffing Services Arlington, United StatesJob Description · Job DescriptionWe are seeking a detail-oriented and experienced Quality Engineer to join our team in Arlington. The primary responsibility of the Quality Engineer is to ensure that all electronic products and components meet the highest quality standards. This p ...
-
Quality Engineer
9 hours ago
Alarm Vienna, United Statesis seeking an experienced Quality Engineer to join the Client team to support our Partner Tools and Operations offerings. The Quality Engineer would be responsible for testing and certifying the multiple web and mobile applications offered to our partners and internal stakeholder ...
-
Quality Engineer
2 weeks ago
Lockheed Martin Corporation Arlington, United StatesJob Description · Lockheed Martin Missiles & Fire Control (MFC) is seeking a dynamic Quality Engineer to join our team in Arlington, TX, providing essential support to the PAC3 Program. This role offers a challenging and rewarding opportunity to ensure the delivery of high-quali ...
-
Quality Engineer
2 weeks ago
Medcura Riverdale Park, United StatesJob Description · Job DescriptionMedcura, Inc. is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs. Leveraging rapid-acting, plant-based hemostatic agents with natural biopolymers, Medcura's ...
-
Quality Engineer
2 weeks ago
Mercury Systems Chantilly, United StatesJob Description · Job DescriptionDuring product development, this role participates in guiding the design for quality, manufacturability and producibility, while ensuring project quality plans are compliant to the customers' requirements and applicable standards and regulations. ...
Manager, Quality Engineering - Rockville, United States - AbelZeta Inc
Description
Job DescriptionJob Description
AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products.
AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US.
We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.
We are seeking a Manager / Sr. Manager, Quality Engineering to join our team.
This position responsible for supporting the site Technical Operations (TechOps) processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV).
Assisting with the commissioning and qualification of AbelZeta's manufacturing site, providing support to the site validation group tasked with implementation of new equipment and manufacturing suites.
Maintaining the Validation Master Plan.Responsibilities and Duties:
Implement / execute computer system validation and general CQV.
Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
Provide support for change control technical
assessment/evaluation
process.
Align on change control requirements to manage the requested change.
Implement qualification procedures.
Responsible for system compliance aspects across the site's project portfolio.
Support the site's quality system management with measurement and control strategies.
Support regulatory inspections and audits.
Manage the risk assessment process for qualification and validation.
Support vendor qualification and compliance audits.
Review
technical/investigation
reports as appropriate.
Write, review, and approve proposed changes to systems and procedures, as appropriate.
Write, review, and approve protocols and summary reports.
Track, review, and report metric information for use in continuous improvement of areas of responsibility.
Support QE Director on continuous improvement initiatives and projects within the site's quality organization.
Perform other duties and tasks as assigned.
Qualifications and Requirements:
Bachelor's degree in technical discipline (Computer Science/ Industrial Engineering or similar).
Minimum of 3 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).
Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
Automation, equipment, and utility IQ/OQ/PQ/PV.
Quality Assurance, GMPs, Health Authority Regulations and Validation
practices/principles.
Strong knowledge of GMP, GAMP, SOPs, and quality systems.
Experience with internal and external audit principles.
Strong knowledge of change control
practices/strategies.
Proficient in MS Word, Excel, PowerPoint, and other applications.
Ability to communicate and work independently with
scientific/technical
personnel.
Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.
Ability to work in a dynamic, fast paced environment with shifting prioritiesAbility to work collaboratively with teams and collaborators.
Why You Should Join AbelZeta
Join a high-growth and fast-paced organization.
Defined career path and annual performance review and feedback process.
Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
Competitive company 401k match.
Paid holidays, sick leave, and annual leave.
AbelZeta is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
AbelZeta validates right to work using E-Verify.Salary at AbelZeta is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements.
The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta's total compensation package for employees.
#J-18808-Ljbffr