Randstad Project Manager III in Waltham, Massachusetts
Project Manager III
salary:$39.38 - $46.33 per hour
date posted:Thursday, June 10, 2021
industry:Professional, Scientific, and Technical Services
Project Manager III
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location: Waltham, Massachusetts
job type: Contract
salary: $39.38 - 46.33 per hour
work hours: 9 to 5
The SCES Q manager Person in Plant 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 company 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 company 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.
- Bachelor's degree and 10+ years of experience working in a cGxP or other regulated environment, with 3+ years of experience in a Quality role.
skills: Project Management, Quality control, Quality Assurance, 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.
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