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.
Must Have Skill Sets:
Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment.
Experience collaborating within and across functional areas, with a strong focus on customer service and partnership.
GMP experience (either MFG or QA)
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.
#LI-AS140
Numbers & Facts
Location
West Greenwich, RI
Skills
Asepsisunmatched
Biologyunmatched
Cleanroomunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Support/Serviceunmatched
Document Managementunmatched
Documentationunmatched
Establish Prioritiesunmatched
Facilities Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
IBM Maximo Asset Managementunmatched
Laboratoryunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Operationsunmatched
Manufacturing Process Management (MPM)unmatched
Microsoft Excelunmatched
Microsoft Officeunmatched
Microsoft Outlookunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Pest Controlunmatched
Presentation/Verbal Skillsunmatched
Procedure Developmentunmatched
Process Developmentunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
Safety Complianceunmatched
Specimens/Samplesunmatched
Warehousingunmatched
Writing Skillsunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.