Job Title:              Quality Assurance Associate

Location:              Waltham , Massachusetts -  02451  

Job Type:              Contract

Duration:               6+ Months

About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives

Job Description:

Essential Job Responsibilities:

The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks.. Years of Experience: 6 - 9 Years 

• This position will be 100% remote for the life of the contract (6months)
• Quality Assurance professional preferably with experience with contract manufacturers.
  Core Responsibilities
• Release product in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  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 (biologics).
• Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.

Additional Responsibilities:

• Provide QA project manager support for change controls and other projects.
• Support program for maintaining performance metrics.  

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:       Sangeeta Choudhury  

Email:             

Phone:             678 -890-5107