Position Title: Quality Control Review Resource I (GPV)
Work Location: Westborough, MA, 01581
Assignment Duration: 03 Months (Possible extension)
Work Arrangement: Onsite
 
Position Summary:
Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports. Performs data integrity review of CMC data and reports intended for regulatory filings.
Key Responsibilities:

• Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports.
• Performs data integrity review of CMC data and reports intended for regulatory filings.
• Ensures integrity, accuracy, and consistency of data and documents.
• Record QC metrics per defined categories.

 
Qualifications & Experience:

• BA/BS or equivalent with typically 3+ years relevant experience in a biotechnological and/or pharmaceutical Quality Assurance setting.
• Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products.
• Excellent oral and written communication skills.
• Ability to perform and verify mathematical determinations utilizing both calculator and computer programs, such as Excel.
• Ability to work effectively in a matrix setting to resolve issues and achieve common goals.

Preferred:

• Previous experience with cell therapy development or cell-based assays (technical or quality review).
• Experience working under GxPs and/or knowledge of GMP, ICH, USP and global compendial regulations and guidance.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 48.00/hr.