Senior QA Associate — On-the-Floor cGMP Oversight

US Tech Solutions; West Greenwich (RI); On-site; USD 70,000 - 100,000; Full time

Job summary

US Tech Solutions is seeking a Plant Quality Assurance professional for a 12-month contract in Rhode Island. You will provide on-the-floor QA oversight for Facilities and Engineering, Process Development, IQA, and Manufacturing, ensuring all bulk drug substance operations meet cGMP and regulatory requirements.

Collaborate with cross-functional teams to review and approve documentation, logs, and MES records, and to identify quality risks.

Qualifications

• Bachelor's degree in Life Sciences.
• Minimum 2 years of Quality or Manufacturing experience with exposure to F&E activities.
• Strong understanding of cGMP principles and regulatory expectations.
• Experience using enterprise systems Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) for quality oversight and documentation.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams).
• Excellent written and verbal communication skills.
• Experience collaborating across functional areas with a customer-service mindset.
• Ability to make sound decisions in a dynamic, fast-paced environment.
• Ability to prioritize and navigate ambiguity with minimal oversight.

Responsibilities

• Provide on-the-floor QA oversight for F&E, IQA warehouse areas and Process Development labs.
• Ensure facilities, equipment, materials, processes and products comply with cGMP and regulatory requirements.
• Review and approve work orders and job plans within Maximo.
• Review logs, pest control reports, RT reports, and GMP documentation.
• Review/approve MES records (EBRs and ESPs).
• Handle of reject materials and Delta V Audit Trail entries.
• Ensure deviations are documented per approved processes.
• Communicate across PQA, PD, IQA, F&E, and Manufacturing to complete tasks.
• Complete required compliance trainings.
• Identify and elevate quality, compliance, or safety risks to management.
• Maintain 25% cleanroom presence with proper gowning and aseptic practices.

Skills

Prioritization

Cross-functional collaboration

GMP experience

Education

Bachelors in Life Sciences

Tools

Maximo

OEFM

MES

Veeva Vault

Job description

US Tech Solutions is seeking a Plant Quality Assurance professional for a 12-month contract in Rhode Island. You will provide on-the-floor QA oversight for Facilities and Engineering, Process Development, IQA, and Manufacturing, ensuring all bulk drug substance operations meet cGMP and regulatory requirements.

Collaborate with cross-functional teams to review and approve documentation, logs, and MES records, and to identify quality risks.