Quality Assurance Senior Associate

Aptask Global Workforce (AGW) is seeking a Quality Assurance Senior Associate for an Onsite position with a Global Biotechnology Company located in West Greenwich, RI. This is a 12+ month contract opportunity.

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.

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 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

Requirements:

• Bachelor's Degree in a relevant field (e.g. Life Sciences) with 6+ months of work experience OR Associate's Degree with 2+ years of work experience OR High school/GED with 4+ years of work experience
• Minimum of 2 years 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)
• 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 and prioritize in a dynamic, fast-paced environment with minimal oversight

Pay range: up to $28.85 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.