Job Details

Title: Quality Assurance Senior Associate
Location: West Greenwich, RI 02817
Duration: 12 Months (Possibility of extension)
Schedule: 100% Onsite - Night shift starts 6:45 pm, Standard 12 hours rotation

Job Overview
We are seeking a detail-oriented professional responsible for quality oversight activities related to Large Molecule manufacturing, including Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) at contract manufacturing sites supporting us.
This role involves reviewing and translating technical documentation into English, ensuring compliance with cGMP standards, and collaborating closely with on-site quality teams.

Must-Have Skills (Top 3):

• Strong understanding of cGMP / Good Documentation Practices
• Excellent communication skills (written & verbal)
• Ability to follow written procedures (SOPs) strictly

• Poor communication skills
• Inability to work in a team environment
• Failure to follow written procedures
• Unwillingness to work night shifts / rotational schedule

• Perform quality oversight functions for BDS, DP, and FP manufacturing
• Review and translate:
  • Batch records
  • Investigations
  • Change controls
  • Complaint documentation
• Ensure compliance with cGMP and Good Documentation Practices
• Assist production teams in maintaining quality standards
• Interpret and apply Standard Operating Procedures (SOPs)
• Communicate effectively with:
  • Internal quality teams
  • Contract manufacturing site personnel
• Provide shift handover updates to incoming team members

• Knowledge of process and facility equipment
• Experience in pharmaceutical, biotech, or medical device industry
• Basic proficiency in Microsoft Word
• Strong teamwork and collaboration skills
• Ability to interpret technical documentation
• Fluency in required language (written & spoken)

• High School Diploma / GED + 4 years of experience, OR
• Associate Degree + 2 years of experience, OR
• Bachelor's Degree + 6 months of experience, OR
• Master's Degree

• Review and verify documentation for accuracy and compliance
• Support production activities under cGMP guidelines
• Follow established procedures and SOPs
• Maintain continuous communication during shift
• Ensure smooth handover between shifts