QA Associate II

This is a second shift position, from 3:00 pm - 11:30 pm with weekend availability required.

About Us

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary

The incumbent is responsible for independently performing batch record reviews and making final disposition decisions for manufactured and packaged drug products. This role ensures that all batches meet specifications, are manufactured and packaged according to validated processes and procedures, comply with cGMPs, and meet both client and regulatory requirements.

Key Responsibilities

• Review, approve, and release manufacturing, packaging, and clinical batch records, along with auxiliary documentation.
• Prepare product release summaries and create Certificates of Analysis/Compliance, as applicable.
• Review laboratory test results against official specifications and prepare product release documentation and summaries.
• Ensure that Aveva batch releases are performed according to current approved Standard Operating Procedures. Confirm that all supporting documents are received and compliant before release, and that any non-conformances are resolved.
• Report and approve all deviations in manufacturing, packaging, and quality control as per Standard Operating Procedures. Ensure deviation reviews assess the impact on the market release of the product.
• Conduct Enterprise Resource Planning (ERP) transactions as part of the release procedure.
• Attend scheduling meetings to coordinate material release priorities, as applicable.
• Communicate any potential delays in batch releases for manufacturing, R&D, or commercial distribution.
• Assist with investigation reports and CAPAs in the Quality Management System (QMS), and support special projects as needed.
• Write reports and correspondence as required.
• Collaborate as part of a team to achieve departmental goals.
• Demonstrate strong written and verbal communication skills in English.
• Exhibit excellent organizational and time management skills.
• Follow instructions according to written procedures.
• Manage multiple priorities in a fast-paced and dynamic environment.
• Operate in compliance with the company’s Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Perform other duties as assigned by the manager.
  
  

Education

• Bachelor’s degree in a STEM related field
  
  

Experience

• Four (4) to six (6) years of progressive experience working for a pharmaceutical and/or pharmaceutical manufacturing company with knowledge of pharmaceutical manufacturing processes and quality systems is required.
  
  

Knowledge, Skills, And Abilities

• Strong attention to detail, accuracy, and reliability in all tasks.
• Excellent written and verbal communication skills in English.
• Proficient in Microsoft Office Suite (Word, Excel, Access, PowerPoint). Experience with ERP systems and Quality Management Systems (QMS) is a plus.
• Strong interpersonal skills with the ability to collaborate effectively within and across departments in a team environment.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Experience working with cGMP procedures in pharmaceutical and/or combination device manufacturing settings.
  
  

Benefits

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday
  
  

Equal Opportunity Employer