QA Associate VQM Aseptic Manufacturing & Packaging

Synerfac Technical Staffing; Whippany (NJ); On-site; USD 5,786,000 - 7,164,000; Full time

Job summary

Synerfac Technical Staffing in Whippany, NJ seeks a QA Associate VQM for aseptic manufacturing and packaging to support vendor quality management and ensure supplier compliance with regulatory standards. This on-site role works with cross-functional teams to uphold quality across vendors.

The ideal candidate has a pharmacy or life sciences background with 2–4 years in pharmaceutical QA, familiarity with GMP, and strong documentation skills for audits and CAPA.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field.
• 2–4 years in Quality Assurance in pharma/biologics manufacturing.
• Experience in aseptic operations or CDMO environment preferred.
• Familiarity with vendor management, supplier qualification, and audits.
• 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 CDMO environment.

Responsibilities

• Support vendor qualification, requalification, and performance monitoring.
• Review and maintain AVL and vendor files.
• Assist audits planning, coordination, and CAPA tracking.
• Review CoA and supplier documentation for compliance.
• Draft and maintain Quality Technical Agreements with suppliers.
• Collaborate with internal stakeholders on vendor-related issues.
• Support investigations related to vendor materials.
• Monitor vendor performance metrics and prepare reports.
• Ensure aseptic quality standards in sourced materials.
• Maintain GMP/cGMP compliance in vendor activities.

Skills

Quality Assurance

Vendor management

Audits

cGMP

Regulatory knowledge

Education

Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or related field

Job description

Job Details

Scientific

QA Associate VQM Aseptic Manufacturing & Packaging Whippany,NJ Job Description Job ID#:122603

Category: Scientific

Job Type: Permanent

Branch: Parsippany

Salary: $ 50.00 - $ 50.00

Phone: [phone]

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

• 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

Job Requirements

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.