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Senior Specialist, Quality Assurance for Quality Control

ISite Technologies Inc

Norwood, Massachusetts • Today

Easy Apply

Full-time

Depends on Experience

Senior QA Specialist QC Laboratory Equipment Qualification (CQV)

Career Soft Solutions Inc

Norwood, Massachusetts • Today

Easy Apply

Contract

$53

Data Center QA/QC Specialist - Site Inspector

Motion Recruitment Partners, LLC

Remote or Amarillo, Texas • Today

Easy Apply

Full-time

Senior Electrical Engineer - MEP

ilocatum

Natick, Massachusetts • Today

Full-time

Compensation information provided in the description

Senior Electrical Engineer

The LiRo Group

Newton, Massachusetts • Today

Full-time

USD 150,000.00 - 180,000.00 per year

Associate Vice President Bridge Structural Lead

The LiRo Group

Newton, Massachusetts • Today

Full-time

USD 185,000.00 - 215,000.00 per year

Senior Radiologic Technologist

Boston Children\'s Hospital

Waltham, Massachusetts • Today

Full-time

Senior Radiologic Technologist

Boston Children\'s Hospital

Waltham, Massachusetts • Today

Full-time

Radiologic Technologist

Boston Children\'s Hospital

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

Radiologic Technologist

Boston Children\'s Hospital

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

Senior AI Infrastructure Platform Engineer, Assistant Vice President

State Street Corporation

Quincy, Massachusetts • 19d ago

Full-time

USD 90,000.00 - 157,500.00 per year

Radiologic Technologist

Boston Children's Hospital

Boston, Massachusetts • Today

Full-time

USD 33.60 - 60.49 per hour

Sr Substation Structural Engineer

Stantec

Hingham, Massachusetts • Today

Full-time

USD 121,300.00 - 182,100.00 per year

MRI Technologist

Boston Children\'s Hospital

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

MRI Technologist

Boston Children\'s Hospital

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

Engineer III, Validation

Thermo Fisher Scientific

Plainville, Massachusetts • Today

Full-time

USD 134,202.00 - 138,900.00 per year

Senior Mechanical Design Engineer / Robotics

Motion Recruitment Partners, LLC

Boston, Massachusetts • Today

Easy Apply

Full-time

$150000 - $172000

MRI Technologist

Boston Children's Hospital

Boston, Massachusetts • Today

Full-time

USD 93,537.00 - 168,355.00 per year

Senior Distribution Engineer (Northeast Region)

Burns & McDonnell

Newton, Massachusetts • Today

Full-time

USD 145,000.00 - 240,000.00 per year

Structural Engineer

McClure Engineering

Boston, Massachusetts • Today

Full-time

Senior Underground Engineer (Northeast Region)

Burns & McDonnell

Newton, Massachusetts • Today

Full-time

USD 150,000.00 - 220,000.00 per year

Senior Transmission Engineer - Overhead Transmission (Northeast Region)

Burns & McDonnell

Newton, Massachusetts • Today

Full-time

USD 135,000.00 - 220,000.00 per year

Electrical Engineer (Transportation)

HDR, Inc.

Boston, Massachusetts • Today

Full-time

MRI Technologist - 3 days per week - Kenmore - Atrius Health

Optum

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

Senior Quality Assurance Analyst

InfiCare

Hybrid in Quincy, Massachusetts • 14d ago

Easy Apply

Third Party, Contract

Depends on Experience

Senior Structural Engineer

HDR, Inc.

Boston, Massachusetts • Today

Full-time

Senior Full Stack Software Developer

Waters Corporation

Milford, Massachusetts • Today

Full-time

Staff Electrical Engineer - Substation (Northeast Region)

Burns & McDonnell

Newton, Massachusetts • Today

Full-time

USD 105,000.00 - 175,000.00 per year

ATE Mechanical Engineer III/IV

Textron, Inc.

Wilmington, Massachusetts • Today

Full-time

USD 115,800.00 - 176,200.00 per year

Engineer II, Facilities

ElevateBio

Waltham, Massachusetts • Today

Full-time

USD 125,000.00 - 165,000.00 per year

Job Details

Skills

Analytical Skill
Quality Management
Microsoft Office
Quality Assurance
Management
Mergers and Acquisitions
Microbiology
Good Manufacturing Practice
Laboratory Equipment
Quality Control
Documentation
Forms
GMP
GxP
Regulatory Compliance
Change Control
Chemistry
Data Integrity
Decision-making
Auditing
Biochemistry
Biology
Biotechnology
Cadence
GC
Risk Management
Standard Operating Procedure
Team Building
Testing
Training

Summary

Title: Senior Specialist, Quality Assurance for Quality Control

Function/Department: Global Drug Substance QA

Regulatory Relevance: GxP

Location: Norwood, MA

or USC

The Role: (Summary)

In this role, you will be responsible for providing quality oversight, guidance, and decision-making for Quality Control (QC) equipment moves, qualification activities and decommissioning activities across Moderna Norwood sites. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP laboratories. This Sr. Specialist of QA for QC provides support primarily for Norwood QC lab instrument activities.

Key Responsibilities and if appropriate Authorities of the Position:

Reviews and approves documentation associated with QC laboratory equipment, including qualification/validation protocols and reports, periodic reviews, method SOPs, forms, and data tables, to ensure equipment readiness, data integrity, and compliance with applicable regulations and cGMP requirements.
Reviews QC logbooks.
Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Ensures QC personnel follow Good Documentation Practices and Data Integrity requirements.
Identify, assess, classify, review, and approve deviations, change controls, work orders, SOPs, CAPAs and other documents related to QC equipment/instrument activities.
Make quality decisions to ensure compliance with internal procedures and external regulations.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Required Background:

Education: Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
Experience: 3-8 years experience in CQV activities within the biotechnology/biopharmaceutical industry, or other regulated industry within a GMP environment. Preferably in Quality Assurance and/or Quality Control.
Specific Certifications or Training: None
Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
Familiarity with equipment qualification/CQV activities.
Experience in analytical or microbiological general QC testing or analytical techniques, method validation, and method transfer.
Experience with deviation management, change control, risk management and digital solutions for quality systems.
Proficiency in Kneat (or equivalent software application), Microsoft Office tools and statistical programs/software.
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90718572
Position Id: 9105840
Posted 23 hours ago

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Contact the job poster

Manideep Chivurala

Team Lead @ ISite Technologies Inc

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Norwood, Massachusetts

•

Today

Senior Specialist, Quality Assurance for Quality Control Location: Norwood, MA 6- 12 Months Contract W2 only The Role: (Summary) In this role, you will be responsible for providing quality oversight, guidance, and decision-making for Quality Control (QC) equipment moves, qualification activities and decommissioning activities across Moderna Norwood sites. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP labo

Easy Apply

Contract

$53

CSV Engineer

Boston, Massachusetts

•

Today

Job Description: Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require. Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, do

Full-time

QC Senior Scientist- Raw Materials

Portsmouth, New Hampshire

•

Today

Job Title: QC Senior Scientist ? Raw Materials Location: Portsmouth, NH (On-site) As a QC Scientist I, Raw Materials, you will support the testing and release of raw materials used in the manufacture of life-changing therapies. Working within the Quality Control team, you will perform laboratory testing, support method transfers and validations, investigate quality events, and collaborate with cross-functional teams to ensure materials meet quality and regulatory requirements. This role is an

Full-time

Validation Engineer

West Greenwich, Rhode Island

•

26d ago

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac

Full-time

USD 85,878.05 - 116,187.95 per year