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Quality Assurance Senior Associate #26-14105

US Tech Solutions, Inc.

West Greenwich, RI

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JOB DETAILS
SALARY
$26–$27.84 Per Hour
SKILLS
Asepsis, Biology, Cleanroom, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Document Management, Documentation, Establish Priorities, Facilities Engineering, GMP (Good Manufacturing Practices), High School Diploma, IBM Maximo Asset Management, Laboratory, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Process Management (MPM), Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Pest Control, Presentation/Verbal Skills, Procedure Development, Process Development, Quality Assurance, Regulations, Regulatory Requirements, Risk Management, Safety Compliance, Specimens/Samples, Warehousing, Writing Skills
LOCATION
West Greenwich, RI
POSTED
6 days ago
Duration: 12 months contract
Shift: Standard Working Hours
 
Job Description:
In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on-the-floor quality oversight for Facilities and Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), and Manufacturing operations. This position requires close collaboration with cross-functional teams to ensure that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements.
 
Key Responsibilities:
  • Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories.
  • Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements.
  • Review and approve work orders and job plans within Maximo.
  • Review logbooks (paper-based and electronic), particle-generating forms, pest control sighting forms, and periodic pest control (monthly/quarterly) reports, RT reports, and other GMP documentation.
  • Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
  • Handling of reject materials
  • Review/Approve Delta V Audit Trail entries
  • Ensure that any deviations from established procedures are properly documented according to approved processes.
  • Communicate and collaborate effectively across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure completion of assigned tasks.
  • Complete required training assignments to maintain compliance and readiness for task execution.
  • Proactively identify and escalate quality, compliance, or safety risks to management.
  • Maintain a presence in cleanroom areas (~25% of shift time), including proper gowning and adherence to aseptic practices.
 
Preferred Qualifications:
  • Bachelor’s Degree in a relevant field (e.g. Life Sciences)
  • Minimum of 2 year of experience in Quality or Manufacturing, with exposure to F&E-related activities.
  • Strong understanding of cGMP principles and regulatory expectations.
  • Demonstrated experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes.
  • Proficient in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams.
  • Excellent written and verbal communication skills.
  • Experience collaborating within and across functional areas, with a strong focus on customer service and partnership.
  • Demonstrated ability to make sound decisions in a dynamic, fast-paced environment.
  • Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment.
 
Basic Qualifications:
  • Master's Degree, OR
  • Bachelor's Degree and 6 months experience, OR
  • Associate's degree and 2 years’ experience, OR
  • High school diploma/GED and 4 years’ experience
 
Top Must Have Skill Sets:
  • Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
  • GMP experience, including exposure to F&E related tasks
  • Experience with decision making
 
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

 US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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About the Company

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US Tech Solutions, Inc.