QA/Manufacturing Associate (Plant QA)

Aequor; West Greenwich (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Aequor is seeking a Quality Assurance Senior Associate for an onsite, 12-month contract in West Greenwich, RI. The role provides on-the-floor quality oversight for facilities, development, IQA, and manufacturing, ensuring cGMP compliance.

The position requires close cross-functional collaboration, adherence to GMP documentation, and strong communication skills. 100% onsite with a daily shift and 6:45 AM start window.

Qualifications

• Bachelor’s Degree in Life Sciences or related field.
• Minimum 2 years in Quality or Manufacturing with F&E exposure.
• Strong knowledge of cGMP principles and regulatory expectations.
• Experience using Maximo, OEFM, MES, and Veeva Vault to support quality oversight.
• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams).
• Excellent written and verbal communication skills.
• Ability to collaborate across functions with a customer-service mindset.
• Ability to prioritize and make decisions in a fast-paced environment.

Responsibilities

• Provide quality oversight for F&E, IQA Warehouse areas and PD 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 logbooks, pest control forms, RT reports, and GMP documentation.
• Review and approve MES records including EBRs and ESPs.
• Handle of reject materials.
• Escalate quality, compliance, or safety risks to management.
• Communicate across PQA, PD, IQA, F&E, and Manufacturing to ensure task completion.
• Maintain aseptic practices with ~25% floor presence in cleanrooms.
• Complete required training and stay compliant.

Skills

cGMP principles

Quality oversight

Maximo

OEFM

MES

Veeva Vault

Microsoft Office

Team collaboration

Communication skills

Decision making

Education

Bachelor’s Degree in Life Sciences

Tools

Maximo

OEFM

MES

Veeva Vault

Job description

Title: Quality Assurance Senior Associate (Onsite Job in West Greenwich RI)

Terms: Contract W2 Only

Duration: 12 Months Contract assignment (with possible extension)

Description:

Note:

100% onsite ARI

Schedule: Administrative Shift | 6:45 AM – 3:15 PM (with 30 minute meal break)

Contract Length: 12 months with potential for extension

Position Overview:

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
• 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 escalation 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.