QA Associate VQM

Out client is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. They have a long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

The QA Associate will support Vendor Quality Management activities for aseptic fill operations within a CDMO environment. The role ensures that suppliers, contract laboratories, and service providers meet applicable regulatory requirements, internal quality standards, and client expectations. This position will partner with cross-functional teams (Quality, Manufacturing, Supply Chain, and Technical Operations) to ensure that vendor-related quality systems are effectively managed and compliant with US FDA (21 CFR Parts 210, 211, 820), EU GMP Annex 1, and ISO standards.

This role is 100% on site in Whippany, NJ.

• Support vendor qualification, requalification, and performance monitoring processes.
• Review and maintain Approved Vendor Lists (AVL) and associated vendor files.
• Assist in planning, coordination, and follow-up of vendor audits, including documentation of audit reports and tracking of CAPAs.
• Review vendor-supplied documentation such as Certificates of Analysis (CoA), quality agreements, material specifications, and technical data for compliance.
• Support drafting, negotiation, and maintenance of Quality Technical Agreements (QTA) with suppliers and service providers.
• Collaborate with internal stakeholders to ensure vendor-related issues (e.g., deviations, complaints, change controls) are addressed and resolved in a timely manner.
• Support investigations related to vendor-supplied materials, components, or services impacting aseptic operations.
• Monitor and trend vendor performance metrics and prepare periodic reports for Quality Management Review.
• Ensure adherence to aseptic quality standards in materials and services sourced for sterile operations.
• Maintain compliance with global GMP, cGMP, and client-specific requirements in all vendor quality activities.

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• 2-4 years of experience in Quality Assurance within pharmaceutical/biologics manufacturing; experience in aseptic operations and/or CDMO environment strongly preferred.
• Familiarity with vendor management, supplier qualification, and audit processes.
• Knowledge of cGMP, EU Annex 1, FDA regulations, and ISO 13485.
• Strong organizational, communication, and technical writing skills.
• Ability to work cross-functionally in a dynamic, fast-paced CDMO environment.

• Attention to detail and strong compliance mindset.
• Ability to analyze data and identify trends.
• Skilled in maintaining collaborative relationships with vendors and internal teams.
• Proactive in problem-solving and continuous improvement.

• Primarily site-based with routine presence in classified cleanroom environments.
• May require gowning certification for Grade A/B aseptic areas.
• Occasional travel for supplier audits, training, or regulatory inspections.

Pay is $45.00 - $50.00/hr