QA Associate VQM

Synerfac Technical Staffing

Whippany, NJ

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JOB DETAILS

SALARY

$45–$50 Per Hour

SKILLS

Analysis Skills, Asepsis, Biology, Biotech and Pharmaceutical, Change Control, Cleanroom, Code of Federal Regulations, Communication Skills, Continuous Improvement, Contract Manufacturing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation, Dosage Forms, Drug Manufacturing, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Laboratory, Maintain Compliance, Manufacturing, Negotiation Skills, Organizational Skills, Performance Analysis, Performance Metrics, Pharmacy, Problem Solving Skills, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Requirements, Reporting Skills, Supply Chain Operations, Systems Administration/Management, Team Player, Technical Operations, Technical Writing, Time Management, Trend Analysis, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Quality Management, Vendor/Supplier Relations, Writing Skills

LOCATION

Whippany, NJ

POSTED

10 days ago

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.

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 is $45.00 - $50.00/hr

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.
Must be 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.

Skills & Competencies:
* 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.
Physical Requirements:
* 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.

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About the Company

Synerfac Technical Staffing

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