QA Associate II - Biologics Manufacturing

City of Hope; California, Duarte (MO, CA); On-site; USD 50,000 - 80,000; Full time

Job summary

Join a pioneering research institute dedicated to transforming lives through innovative medical research. As a Quality Assurance Associate II, you will play a crucial role in supporting biological manufacturing, ensuring compliance with stringent regulations, and contributing to the development of biopharmaceutical products. This position offers an exciting opportunity to work alongside a dedicated team committed to advancing the fight against cancer and other serious illnesses. If you have a passion for quality assurance and a desire to make a difference, this role is perfect for you.

Qualifications

• 3+ years supporting biologics manufacturing or GMP operations.
• Basic knowledge of biology, chemistry, or engineering.

Responsibilities

• Conduct quality assurance activities to ensure GMP compliance.
• Review production batch records and compile master records.
• Train new associates on GMP principles and safety.

Skills

Quality Assurance

GMP Compliance

Documentation Practices

Biological Manufacturing

Training

Education

Bachelor's Degree

Master's Degree

Tools

Inventory Databases

Job description

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

We are seeking a Quality Assurance Associate II to support biological manufacturing. You will assist the QA Manager and Senior QA Associate in ensuring compliance with all Federal and State laws, regulations, and accrediting agency requirements related to the collection, processing, preparation, and distribution of biopharmaceutical products in GMP facilities at City of Hope.

Key Responsibilities:

1. Conduct quality assurance activities to ensure GMP compliance, including initiating Change Controls, investigating QMRs and CAPAs, and overseeing documentation processes.
2. Review production batch records to verify proper procedures and processes, and compile and archive master production and control batch records.
3. Conduct external vendor audits and collaborate with internal departments as directed.
4. Participate in internal audits of QA, Manufacturing, or QC processes and assist with audit report writing.
5. Train new associates on GMP principles, Good Documentation Practices, Aseptic Techniques, Gowning, and Safety; update training records accordingly.
6. Conduct inventories of cold storage units and maintain inventory databases.
7. Respond to emergency calls related to critical equipment monitoring as part of the on-call rotation.

Qualifications:

• Bachelor's degree with 3+ years supporting biologics manufacturing, small molecule synthesis, or GMP operations; Master's degree with similar experience or Bachelor's with 5+ years preferred.
• Basic knowledge of biology, chemistry, virology, or engineering.
• Experience with biosafety, chemical safety, cGMP principles, and equipment maintenance is preferred.
• Certification from ASQ or similar organizations is highly preferred but not required.

Additional Information:

City of Hope offers compensation based on experience, qualifications, and location. We are an equal opportunity employer committed to diversity, equity, and inclusion. For more information about our benefits and policies, please visit our website.