Quality Assurance (QA) Specialist - W2 Contract | Jersey City, NJ

Location: Jersey City, NJ, Onsite

Employment Type: W2 Contract

Duration: 1+ Year

We are looking for an experienced Quality Assurance (QA) Specialist to join a leading biopharmaceutical organization. If you have a strong background in Quality Management Systems (QMS), Good Distribution Practice (GDP), and pharmaceutical quality assurance , we'd love to hear from you.

Key Responsibilities:

• Support the Quality Assurance team in managing Quality Management Systems (QMS).
• Maintain and manage product complaint handling and product release processes.
• Ensure compliance with Good Distribution Practice (GDP) and applicable FDA regulations, including 21 CFR Part 210/211 and 21 CFR Part 820 .
• Review and approve quality system documentation, SOPs, and quality-related activities.
• Support continuous improvement initiatives within the Quality Management System.
• Collaborate with Corporate QA teams to maintain and enhance quality systems.
• Assist with internal and external audits, including Third-Party Logistics (3PL) providers.
• Provide quality compliance guidance and training to internal teams.
• Support documentation, electronic quality systems, and serialization initiatives.
• Stay updated with industry regulations, best practices, and regulatory guidance.

Required Qualifications :

• 3–5 years of Quality Assurance experience within the pharmaceutical, biotechnology, or life sciences industry .
• Strong experience with Quality Management Systems (QMS) and Good Distribution Practice (GDP) .
• Knowledge of FDA regulations, including 21 CFR Part 210/211 and 21 CFR Part 820 .
• Excellent verbal and written communication skills.
• Strong attention to detail with the ability to work collaboratively in a regulated environment.

Why Apply?

• Long-term W2 Contract (1+ Year) opportunity.
• Hybrid work model in Jersey City, NJ .
• Opportunity to work with a leading biopharmaceutical organization on critical quality initiatives.

Interested candidates are encouraged to share their updated resume at: ***email_hidden***

We look forward to connecting with you and discussing this opportunity further!