Top 1099 Quality assurance lead Jobs in Dedham, Ma

Principal Associate II, Quality Assurance Operations
Replimune —Framingham, MA
- $134,000 - $173,500 a year
- Full-time
- 6 years
- Management
- Bachelor's degree
- Paid holidays
- Health insurance
Quick Apply
Contact Center Supervisor
The Brigham and Women's Hospital, Inc. —Westwood, MA
- $58,136 - $84,656 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- Supervising experience
- Opportunities for advancement
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Director of Nursing Services
Devereux Skilled Nursing and Rehabilition —Marblehead, MA
- $125,000 - $130,000 a year
- Full-time
- Nursing
- Skilled nursing facility
- RN License
- Health insurance
- Dental insurance
Quick Apply
QMS/QMSR Transition Consultant
NeuroSync Inc. —Holliston, MA
- $160,000 - $180,000 a year
- Full-time
- 5 years
- Mentoring
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
Interim Director of Nursing
Next Step Health Care —Boston, MA
- $75 - $80 an hour
- Contract
- CPR Certification
- Nursing
- Anatomy knowledge
Quick Apply
Primary Care Physician | Community Health | Boston
Whittier Street Health Center —Roxbury Crossing, MA
- $200,000 - $230,000 a year
- Full-time
- Background check
- Medicine
- BC/BE
- AD&D insurance
- Paid holidays
Quick Apply
Day Shift Manager at Cochrane Ventilation LLC
Cochrane Ventilation LLC —Wilmington, MA
- $34 - $44 an hour
- Full-time
- Clean driving record
- English
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
12d
Clinical Director
Brook Behavioral Health —Abington, MA
- $115,000 - $145,000 a year
- Full-time
- Experience working with individuals with developmental disabilities
- HIPAA
- Experience working with children
- Health insurance
- Paid time off
Quick Apply
Director of Nursing Services (DON)
Brookhaven at Lexington —Lexington, MA
- $125,000 - $150,000 a year
- Full-time
- Nursing
- Skilled nursing facility
- RN License
- Health insurance
- Dental insurance
Quick Apply
Senior Electrical Engineer, BSEE
Good Harbor Group —Charlestown, MA
- From $150,000 a year
- Full-time
- Hybrid work
- Hospitality
- Senior level
- Electrical Engineering
- Health insurance
- Dental insurance
Quick Apply
4d
RN, Supervisor (Home Health Assessments)
Activate Care —Boston, MA
- $110,000 - $122,000 a year
- Full-time
- Nursing
- RN License
- Bachelor of Science
- Paid time off
Quick Apply
Physical Therapy (Therapist) Manager Inpatient
Beth Israel Lahey Health —Burlington, MA
- $101,670.40 - $142,355.20 a year
- Full-time
- Acute care
- Customer service
- 5 years
Quick Apply
Proj Mgr-Supplemental Work Engineering
Keolis Commuter Services —Somerville, MA
- $90,000 - $120,000 a year
- Hybrid work
- Background check
- Construction site
- Writing skills
- Disability insurance
- Health insurance
Quick Apply
Solar Quality Assurance Manager
anonymous —Canton, MA
- $100,000 - $125,000 a year
- Full-time
- Management
- Construction site
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Lead / Manager QA Engineer
Motion Recruitment —Boston, MA
- Contract
- Office
- Java
- Analysis skills
Region Manager
Care Access —Boston, MA
- $95,000 - $115,000 a year
- Up to 50% travel
- Inventory management
- Pass drug screening
- Health savings account
- Paid holidays
Assistant Director of Nursing - Skilled nursing
Lafayette rehabilitation and skilled nursing —Marblehead, MA
- $84,512.95 - $101,779.03 a year
- Full-time
- Nursing
- Anatomy knowledge
- Skilled nursing facility
- Health insurance
- Dental insurance
Quick Apply
Supervisor MRI Imaging Operations $20K Sign-On Incentive
Dana-Farber Cancer Institute —Chestnut Hill, MA
- $127,200 - $140,400 a year
- Full-time
- BLS Certification
- 3 years
- Master's degree
- Flexible schedule
Director of Rehabilitation
Reliant Rehabilitation —Brockton, MA
- $80,000 - $100,000 a year
- Management
- Customer service
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
Sr. Vascular Technologist - $15,000 Sign On Bonus
Boston Medical Center —Boston, MA
- $43.03 - $62.50 an hour
- Full-time
- Background check
- Bachelor of Science
- Mid-level
- Health insurance
- Dental insurance
Quick Apply

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Principal Associate II, Quality Assurance Operations

Replimune -
Framingham, MA

Quick Apply

Job Details

Full-time
$134,000 - $173,500 a year

Benefits

Paid holidays
Health insurance
Dental insurance
Vision insurance
401(k) matching

Qualifications

Preventive action implementation
Spreadsheets
Drug regulation
Quality control preventive actions
Corrective and preventive actions (CAPA)
GMP
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Smartsheet
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing projects
Quality control experience within pharmaceutical industry
Productivity software
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key responsibilities:

Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness.
Manage/coordinate internal and external batch release for GMP lots, through batch disposition and subsequent release and issuance of Certificate of Analysis / Conformance.
Manage Product Complaints for Commercial Product
Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process.
Reviewing packaging master batch records, packaging, labeling for investigational medicinal product.
Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events.
Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance, including a summary of findings for any batch that does not meet the standard requirements for final disposition.
Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Oversee progression of batch related Out of Specification investigations and deviations to ensure timely progression for release.
Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities.
Lead, mentor and coach quality assurance personnel through development of training to support batch release activities/processes.
Support internal/external batch release audits as Subject Matter Expert.

Other responsibilities

As assigned

Educational requirements:

Bachelor degree in appropriate Science (chemistry, biology, biochemistry, microbiology) required; MSc or PhD preferred

Experience and skill requirement:

Minimum 6+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality
Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or
engineering.
A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH
guidelines.
Demonstrated knowledge and direct experience with Quality Systems and GxP
compliance within a regulated environment.
Experience managing product complaints is preferred.
Experience managing quality events (i.e. Deviations, CAPA).
Experience with Master Control, Veeva or eQMS systems preferred.
Excel, PowerPoint, Word, SmartSheets proficient
Experience revising procedures and documents.
Excellent attention to detail.
Excellent verbal and written communication and presentation skills across all levels.
Prioritize and manage multiple priorities and projects with little assistance.
Familiarity with clinical and commercial supply areas and processes

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $134,000 $173,500 The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.

Quick Apply

Refine Your Search

quality assurance lead jobs in dedham, ma

Principal Associate II, Quality Assurance Operations

Contact Center Supervisor

Director of Nursing Services

QMS/QMSR Transition Consultant

Interim Director of Nursing

Primary Care Physician | Community Health | Boston

Day Shift Manager at Cochrane Ventilation LLC

Clinical Director

Director of Nursing Services (DON)

Senior Electrical Engineer, BSEE

RN, Supervisor (Home Health Assessments)

Physical Therapy (Therapist) Manager Inpatient

Proj Mgr-Supplemental Work Engineering

Solar Quality Assurance Manager

Lead / Manager QA Engineer

Region Manager

Assistant Director of Nursing - Skilled nursing

Supervisor MRI Imaging Operations $20K Sign-On Incentive

Director of Rehabilitation

Sr. Vascular Technologist - $15,000 Sign On Bonus

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