QA Associate VQM Aseptic Manufacturing & Packaging

Location: Whippany

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. By applying for this job, you agree to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undeliverable messages. You can reply STOP to cancel and HELP for help.

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