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Quality Assurance Senior Associate

Aditi Consulting

West Greenwich, RI

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JOB DETAILS
SALARY
$24–$25 Per Hour
SKILLS
Artificial Intelligence (AI), Asepsis, Automotive Automation, Biology, Cleanroom, Communication Skills, Consulting, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Document Management, Documentation, Establish Priorities, Facilities Engineering, GMP (Good Manufacturing Practices), IBM Maximo Asset Management, Laboratory, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Process Management (MPM), Messaging Technology, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Pest Control, Presentation/Verbal Skills, Procedure Development, Process Development, Purchasing/Procurement, Quality Assurance, Regulations, Regulatory Requirements, Risk Management, Safety Compliance, Short Messaging Service (SMS), Specimens/Samples, Speech Technology, Telephony, Warehousing, Writing Skills
LOCATION
West Greenwich, RI
POSTED
2 days ago
Payrate: $24.00 - $25.00/hr.
 
Summary:
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.
 
Top 3 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
 
Pay Transparency: The typical base pay for this role across the U.S. is: $24.00 - $25.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

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Aditi Consulting