What are the responsibilities and job description for the Quality Assurance (QA) Specialist – W2 Contract | Jersey City, NJ position at Makonis?
📍 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: gunjan.t@makonissoft.com
We look forward to connecting with you and discussing this opportunity further!