Job Title: Quality Assurance Associate

Location: West Greenwich, Rhode Island (100% Onsite)

Contract Duration: 1 Year

Shift Schedule: Rotating Shift:

• Week 1: Monday, Tuesday, Friday, Saturday
• Week 2: Sunday, Wednesday, Thursday
• ~12-hour shifts (6:50 AM – 7:00 PM)

*ONLY ABLE TO ACCEPT W2 AT THIS TIME, NO C2C*

Job Summary:

In this critical role, the Quality Assurance Associate will provide quality oversight and support for manufacturing activities related to bulk drug substance production. This includes real-time decision-making on quality and compliance, ensuring adherence to cGMP (current Good Manufacturing Practices) regulations.

The position involves substantial time in cleanroom environments and collaboration with manufacturing staff to maintain the highest standards of product quality and operational efficiency.

Key Responsibilities:

Quality Oversight:

• Ensure operations, products, and processes comply with cGMP and other applicable regulations.
• Oversee facilities, equipment, materials, and documentation to maintain compliance.

Documentation Review:

• Perform thorough reviews and approvals of GMP documents, including batch records, logbooks, attachments, work orders, and other quality-related documentation.
• Ensure production records and testing results are complete, accurate, and documented per established procedures.

Deviation Management:

• Ensure deviations from established procedures are documented and addressed promptly.
• Alert management to potential quality, compliance, supply, or safety risks.

Cleanroom Activities:

• Gown in and out of frocks and coveralls as required for cleanroom operations.
• Maintain a purposeful presence on the manufacturing floor to support real-time operations.

Collaboration & Communication:

• Work closely with QA shift colleagues to ensure timely completion of required tasks.
• Collaborate within and across functional areas with a customer service focus.

Training & Compliance:

• Complete assigned training to ensure competency in required tasks.

Interim & Reject Cage Management:

• Manage and monitor interim and reject cages to maintain compliance and quality standards.

Required Qualifications:

Basic Qualifications:

• High school diploma/GED with 4+ years of work experience, or
• Associate degree with 2+ years of work experience, or
• Bachelor’s degree with 6+ months of work experience, or
• Master’s degree.

Preferred Qualifications:

• Bachelor’s degree and 2 years of quality or manufacturing experience in a cGMP environment.
• Experience with decision-making, analytical testing, and/or compendia testing.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).
• Strong knowledge of data integrity requirements.
• Excellent written and verbal communication skills.

Top Skills & Experience:

• cGMP Experience: Strong understanding of cGMP regulations and quality systems.
• Collaboration & Customer Focus: Proven ability to work within and across teams while maintaining excellent customer service.
• Ambiguity Management: Ability to prioritize and navigate a fast-paced environment with minimal oversight.