QA Associate: Aseptic Mfg & Packaging – On-Site Whippany

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

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.