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USA-Project Manager II (Clinical)

Job Description

Quality Project Manager #21-06034
Allston, MA
**local candidates

Job Description:
The SCES Q manager at the CLIENT’S plant will acts as the day-to-day liaison with internal and external customers for quality related activities.
  • Ensure GMP compliance of products manufactured and/or tested at a contract facility.
  • Ensure all aspects of product manufacturing and/or testing are reviewed versus established
    quality standards and the applicable marketing authorizations.
  • Manage Quality Systems, e.g. change control, deviations, complaints, and product investigations.
  • Modify, review, and ensure contractor quality standards and protocols for processing materials
    into partially finished or finished product meet the CLIENT’S and GMP requirements.
  •  Contribute to the completion of milestones associated with specific projects.
  • Release product in accordance with approved specifications and procedures.
  • Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and
    accuracy of products and production equipment.
  • Compile data and write summaries for periodic product reviews, investigations, complaints, and
    deviations.
  • Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
    Expert review.
  • Interact with multi-functional internal and external project teams to ensure compliance.
  • Respond to technical and quality issues and handle schedule and/or process-related conflicts.
  • Demonstrate understanding of applicable US and global regulations related to manufacture of
    medicinal products (small molecules and biologics).
  • Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
  • May assist in vendor selection and evaluation.
  • Provide QA project manager support for change controls and other projects.
  • Develop and manage Quality Technical Agreements between the CLIENT and the contractor
  • Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily.
  • Support program for maintaining performance metrics.
 
Job Requirements:
  • Bachelor’s degree
  • 10+ years of experience working in a cGxP or other regulated
    environment, with 3+ years of experience in a Quality role.
  • This position will support the manufacturing operation in Allston, MA. Person needs to be on site

Job Requirements

 

Job Snapshot

Location US-MA-Waltham
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-MA-Waltham
Ramesh Tummala
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Snapshot
Ascent
Company:
US-MA-Waltham
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Quality Project Manager #21-06034
Allston, MA
**local candidates

Job Description:
The SCES Q manager at the CLIENT’S plant will acts as the day-to-day liaison with internal and external customers for quality related activities.
  • Ensure GMP compliance of products manufactured and/or tested at a contract facility.
  • Ensure all aspects of product manufacturing and/or testing are reviewed versus established
    quality standards and the applicable marketing authorizations.
  • Manage Quality Systems, e.g. change control, deviations, complaints, and product investigations.
  • Modify, review, and ensure contractor quality standards and protocols for processing materials
    into partially finished or finished product meet the CLIENT’S and GMP requirements.
  •  Contribute to the completion of milestones associated with specific projects.
  • Release product in accordance with approved specifications and procedures.
  • Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and
    accuracy of products and production equipment.
  • Compile data and write summaries for periodic product reviews, investigations, complaints, and
    deviations.
  • Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter
    Expert review.
  • Interact with multi-functional internal and external project teams to ensure compliance.
  • Respond to technical and quality issues and handle schedule and/or process-related conflicts.
  • Demonstrate understanding of applicable US and global regulations related to manufacture of
    medicinal products (small molecules and biologics).
  • Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
  • May assist in vendor selection and evaluation.
  • Provide QA project manager support for change controls and other projects.
  • Develop and manage Quality Technical Agreements between the CLIENT and the contractor
  • Participate in contractor quality audits and verify any actions taken by the contractor in response to audit observations are completed satisfactorily.
  • Support program for maintaining performance metrics.
 
Job Requirements:
  • Bachelor’s degree
  • 10+ years of experience working in a cGxP or other regulated
    environment, with 3+ years of experience in a Quality role.
  • This position will support the manufacturing operation in Allston, MA. Person needs to be on site

Job Requirements

 
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