Senior QA Associate Plant

Location: West Greenwich RI

Onsite Flexibility: Onsite

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $25.00$27.00 / Hour (USD)
• Shift / Schedule: Administrative Shift 6:45 AM 3:15 PM (with 30-minute meal break)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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.

• 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 rejected 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.

• 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).

• 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.

• High school diploma / GED 4 years of work experience OR
• Associate degree 2 years of work experience OR
• Bachelors degree 6 months of work experience OR
• Masters degree
• Bachelors degree in a relevant field (e.g. Life Sciences) preferred.

• Minimum of 2 years of experience in Quality or Manufacturing with exposure to F&E-related activities (preferred).

• Maintain a presence in cleanroom areas (25% of shift time) including proper gowning and adherence to aseptic practices.

• Red Flag: No GMP experience (biopharmaceutical or pharmaceutical) will disqualify a candidate.
• Interview Process: Video Conference Call with Hiring Manager.

• Medical Vision and Dental Insurance Plans
• 401k Retirement Fund

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking financial services technology life sciences biotech utilities and retail sectors throughout the U.S. and Canada.

Job Number: 26-14068 Industry: Manufacturing & Operations

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