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632 Jobs in Dennis Port, Massachusetts

Thermo Fisher Scientific
Compliance Specialist II

Location Plainville, Massachusetts

Full Time
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ZOLL Medical Corporation
Director, Systems Engineering

Location Chelmsford, Massachusetts

 
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MSPCA-Angell
Veterinary Technician or Assistant - Clinic Department - Are you looking to expand your technical skills?

Location Boston, Massachusetts

Full Time
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Broadmead Medical Services Inc
Staff Software Engineer - Frontend / Fullstack

Location Boston, Massachusetts

Full Time
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Factory Motor Parts
Territory Account Manager

Location Framingham, Massachusetts

Full Time, Contractor
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Uncommon Schools: Roxbury Prep
High School Math Teacher

Location Boston, Massachusetts

Full Time
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Eliot
Psychiatric Medical Assistant

Location Concord, Massachusetts

Full Time
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ClearCompany
LPN/RN - Per Diem

Location Taunton, Massachusetts

Per Diem
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Arrow Search Partners
Executive Assistant

Location Boston, Massachusetts

 
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ClearCompany
Internship

Location Fall River, Massachusetts

Intern
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GREYSTONE
Vice President of Analytics - LIHTC Syndications

Location Boston, Massachusetts

Full Time
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The Inland Real Estate Group of Companies, Inc.
Maintenance Supervisor

Location Ashland, Massachusetts

Full Time
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MSPCA-Angell
Surgical Oncology Assistant

Location Boston, Massachusetts

Part Time
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Sodexo
Cook II

Location East Sandwich, Massachusetts

Full Time
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Elgen Staffing
Maintenance Mechanic

Location Dartmouth, Massachusetts

 
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Acclaro
Chinese Traditional (Taiwan) translators and editors

Location Maynard, Massachusetts

Full Time, Other
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MSPCA-Angell
ER-Triage Technician/Assistant - Veterinary

Location Boston, Massachusetts

Full Time
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Broadmead Medical Services Inc
Customer Service-Self Storage Manager

Location Methuen, Massachusetts

Full Time
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Citizant Inc.
HSPD-12: Government Badging & Credentialing Specialist (Boston - REF1519A)

Location Boston, Massachusetts

Full Time, Contractor
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Thermo Fisher Scientific
Product Manager

Location Waltham, Massachusetts

Full Time
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Sodexo
Plumber

Location Peabody, Massachusetts

Full Time
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Sodexo
Concierge

Location Cambridge, Massachusetts

Other, Full Time
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Eliot
PACT Nurse Case Manager

Location Danvers, Massachusetts

Full Time
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ZOLL Medical Corporation
Military and Federal Government Contracts Manager

Location Chelmsford, Massachusetts

 
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Sodexo
Senior Food Supervisor

Location Framingham, Massachusetts

Part Time
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Thermo Fisher Scientific
Thermo Fisher Scientific

Compliance Specialist II

location Plainville, Massachusetts

Job Type Full Time

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Job Description

Compliance Specialist II

The Compliance Specialist II makes an impact by leading and owning manufacturing investigations, utilizing root cause analysis tools as required to find root cause and contributing factors. Supporting and developing consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems. Conducting complex document revisions and/or document management including batch production records and manufacturing procedures.

Responsibilities:

  • Identify event impact and communicate/present to Manufacturing and Quality.
  • Definition, ownership, and/or support of corrective and preventative actions (CAPA’s) in alignment with Manufacturing requirements.
  • Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations. 
  • Edit cGMP documents and process through workflow for the creation of quality approved documentation.
  • Cross-functional collaboration with document control and other supporting groups is required.
  • Support manufacturing internal and external observations as required.
  • Practice and promote safe work habits while adhering to safety procedures and guidelines.
  • Support and develop consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems.
  • Conduct complex document revisions and/or document management including batch production records and manufacturing procedures. 
  • Own and maintain tracking systems of manufacturing compliance priorities.  
  • Work collaboratively with others to meet group and organizational goals.
  • Participate in initiatives to support innovation and continuous improvement activities.
  • Improve compliance within quality procedures, policies, and regulations. 
  • Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation. 
  • Support manufacturing change control.

Education/Experience

  • Bachelor’s degree in sciences, pharma, biotech, manufacturing, or related field.
  • 2 years’ experience in pharmaceuticals manufacturing or regulated working environment.
  • Manufacturing Operations Experience is preferred.
  • May consider additional years of related industry experience in lieu of degree

Knowledge, Skills, and Abilities

  • Ability to gown aseptically and/or sterile gown as needed.
  • Write, read/review written documentation for extended periods of time.
  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
  • Strong planning, organization, and multitasking skills. 
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.  
  • Solid understanding of applicable regulatory requirements.
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