Quality Assurance Associate - Batch Release Specialist

🌟 Job Opportunity: Associate, Quality-Batch Release/Ops - Princeton, NJ 🌟

🏢 About Us:

We are a leading pharmaceutical company dedicated to advancing healthcare and improving lives through innovative and affordable medicines. Our mission is to make a positive impact on communities by providing access to high-quality pharmaceutical products.

💼 Role: Associate, Quality-Batch Release/Ops

📍 Location: Princeton, NJ

🌈 Diversity, Equity & Inclusion:

We strongly believe in creating a diverse, equitable, and inclusive workplace where every individual's contributions are valued. We welcome candidates from all backgrounds as we strive to build a talented and diverse team.

🎯 Purpose:

Join us in a pivotal role where you will be responsible for ensuring the highest quality standards for our pharmaceutical products. As an Associate, you will play a crucial part in batch record review and batch release processes to maintain compliance with industry regulations.

🔍 Responsibilities:

• Oversee Quality Assurance activities at Contract Manufacturing Organizations (CMOs) involved in the production and packaging of pharmaceutical products.
• Conduct meticulous batch record reviews, encompassing Quality Control, manufacturing, packaging, and Quality Assurance records to ensure accuracy and adherence to standards.
• Collaborate with external partners to identify areas of improvement and ensure compliance with CGMPs and regulatory expectations.
• Work closely with customer service teams to provide necessary documentation and support requests for Certificates of Analysis (COAs).
• Manage Quality Management Systems, including deviation investigation, CAPA, and minor Change Control.

🎓 Qualifications/Skills:

• Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
• Minimum 2 years of experience in cGMP manufacturing. Previous Quality Assurance experience is preferred.
• BA/BS (preferably in Science) or High school diploma with equivalent work experience.

💉 COVID-19 Vaccination:

At our company, we prioritize the health and safety of our employees. We encourage vaccination, and while it is not currently mandated, weekly COVID testing is mandatory for those not fully vaccinated.

🤝 Equal Opportunity Employer:

We are proud to be an equal opportunity employer, committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

🚀 Ready to Make a Difference?

If you are passionate about ensuring top-notch quality in pharmaceutical products and ready to make a positive impact on communities, we'd love to hear from you! Join our dynamic team and contribute to the advancement of healthcare.

📩 Apply Now and Take the Next Step in Your Career!

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