Quality Assurance Senior Associate #26-14105

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.
• Handle 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

About US Tech Solutions

Tech Solutions US is a global staff augmentation firm offering a broad spectrum of talent on-demand and total workforce solutions. For more information about Tech Solutions US, visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.