CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Sr. Specialist , GCP/GLP/GVP Quality Assurance

Company: Randstad USA
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Sr. Specialist , GCP/GLP/GVP Quality Assurance

Sr. Specialist , GCP/GLP/GVP Quality Assurance date posted: Saturday, September 12, 2020

experience: 5 Years

job type: Permanent

industry: Professional, Scientific, and Technical Services

Sr. Specialist , GCP/GLP/GVP Quality Assurance

job summary:

This role is an exciting opportunity to be a part of the Quality Assurance organization. We are looking for a dedicated resource that can contribute to our transition from an early clinical phase Biotechnology company to a company that will support late phase clinical trials.

Reporting to the Sr. Director of GCP/GLP/GVP Quality Assurance, located at the our Headquarters in Cambridge, MA, the Sr. Specialist of GCP/GLP/GVP Quality Assurance, will (i) be a key contributor to, and be responsible for helping to establish and sustain the Quality Management System for the areas of GCP, GLP and GVP, (ii) be a key contributor and support the systems of clinical Corrective Actions/Preventive Actions (CAPAs) and Clinical Issues, and other quality systems for ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). The appointee will also be responsible to partner with clinical study teams and other Clinical Development functions, as necessary, to create a quality culture within our company and help reach a sustained state of inspection readiness.

location: Cambridge, Massachusetts

job type: Permanent

salary: $115,000 - 1,250,000 per year

work hours: 9 to 5

education: Bachelors


Assist in improving overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations.

Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.

Manage the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.

Manage the issuance of audit reports and the tracking/monitoring of corrective responses to audit findings to completion.

Participate in internal audit program and third party/regulatory inspection programs for the Cambridge facility.


BS/BA, with a minimum 5-8 years Quality Assurance experience in Biotech, Pharma or Clinical Research Organization.

Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and/or GLP regulations.

Experience working with CROs, vendors, and relationship management preferred.

Experience managing essential documentation (GCP/GLP/GVP: Policies, SOPs, JDs, Training Records, CVs, etc.) working to good documentation practices.

Familiarity with common Safety databases (e.g. ArisG, Argus) preferred.

Excellent clinical/non-clinical judgment and ability to communicate complex clinical/non-clinical issues in a scientifically sound and understandable way.

Excellent communication skills (verbal and written).

Ability to manage multiple projects in a fast-paced environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

skills: FDA, CAPA, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Randstad USA, Registered office:? One Overton Park, 3625 Cumberland Blvd SE, Atlanta, GA 30339.

RANDSTAD, HUMAN FORWARD and SHAPING THE WORLD OF WORK are registered trademarks of Randstad N.V.

Keywords: Randstad USA, Cambridge , Sr. Specialist , GCP/GLP/GVP Quality Assurance, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Other Jobs

Registered Nurse - Home Care (Position Eligible for $5K Sign On Bonus)
Description: HopeHealth is seeking an experiencedRegistered Nurse for its affiliate HopeHealth Visiting Nurse. In this role you will visitpatients in their homes within a specific geographic area. Position is eligible (more...)
Company: HopeHealth
Location: East Providence
Posted on: 09/24/2020

Amazon Workforce Staffing: Seasonal Amazon Warehouse Operator With $1000 Sign-On Bonus - Up To $18.
Description: Seasonal Reduced-time Warehouse Team Member 1000 sign-on bonusHourly pay rate: Earn 15.25 18.25/hr, plus benefits and a 1000 bonus Limited-Time OpportunityLocation: Milford, MAJob opportunities (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/24/2020

Paragon Rehabilitation: Physical Therapy Assistant - Pta
Description: Paragon Rehabilitationworks across a vast continuum of healthcare environments including hospitals, skilled nursing, assisted living and home health. We foster trust, build relationships, and strive for (more...)
Company: Paragon Rehabilitation
Location: Woonsocket
Posted on: 09/24/2020

Territory Sales Representative **1099 Commission ONLY
Description: Responsibilities: Educate healthcare staff about our product while building value with decision makers Build and maintain relationships with health care providers,
Company: Acquire Health
Location: Concord
Posted on: 09/24/2020

Amazon Workforce Staffing: Order Fulfillment Team Member
Description: Warehouse
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/24/2020

Waste Handling Specialist
Description: Summary Reporting to the Department Director, and under direct supervision of the Manager, collects waste products such as trash, soiled linen and biohazard waste from patient units and disposes of each (more...)
Company: Concord Hospital
Location: Concord
Posted on: 09/24/2020

Customer Service/Sales
Description: Customer Service/Sales 307112461 East Providence, Massachusetts, US, 02914 Position Purpose: Customer Service/Sales associates provide fast, friendly service by actively seeking out customers to assess (more...)
Company: The Home Depot
Location: East Providence
Posted on: 09/24/2020

Submarine Electronics
Description: ABOUT The most secretive of Navy vessels, a submarine requires a select community of specially trained professionals to operate its classified, highly advanced hardware. The Sailors in the Submarine (more...)
Company: Navy
Location: East Providence
Posted on: 09/24/2020

Data Management Configuration Analyst I
Description: Software Configuration Management SW CM will supports the software engineering team. These job duties include preparing Software Review Board SRB monthly meeting agenda, generating SRB minutes, updating (more...)
Company: RTX
Location: Woonsocket
Posted on: 09/24/2020

Amazon Workforce Staffing: Early Morning Shifts Available Permanent
Description: Part-time Warehouse Team Member 250 sign-on bonusHourly pay rate: Earn 15.90/hr- 18.90 , plus benefits and a 250 bonus The base pay for this role is 15.90/hr. We are offering temporary shift premiums (more...)
Company: Amazon Workforce Staffing
Location: Concord
Posted on: 09/24/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds