Our client is a Pharmaceutical is a technology-focused contract development and manufacturing
organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated
expertise in controlled substances manufacturing. With facilities in the United States and Canada,
supports leading pharmaceutical companies through high-quality manufacturing,
operational excellence, and customer-focused solutions.
OVERVIEW
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.
ESSENTIAL FUNCTIONS
KEY RESPONSIBILITIES S
* 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.
Pay rate: $50.00
POSITION QUALIFICATIONS
EDUCATION/EXPERIENCE:
* 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.
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