We are seeking a highly skilled and motivated Quality Assurance (QA) Specialist to join our rapidly growing and dynamic COUR Team. COUR is a clinical-stage biopharmaceutical company located in Skokie, Illinois with the goal of developing first-in-class innovative therapeutic products designed to reprogram the immune system to treat autoimmune disorders from pre-clinical development through FDA approval and commercialization.
The QA Specialist will be responsible for providing vital quality leadership to ensure that the quality system, manufacturing process and drug products comply with cGMPs and all applicable government, customer, and company expectations for quality and safety.
In addition to your contribution to building out a world-class quality assurance organization, you will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
- Perform batch record review on all Drug Product batches
- Assist in Out of Specification (OOS) Investigations.
- Implement corrective actions needed, as required.
- Author, review, approve and coordinate validation (lab, process, and method), qualification (DQ/IQ/OQ/PQ) and requalification activities.
- Use expertise to ensure methods, process, equipment and systems remain in compliance.
- Author and revise Standard Operation Procedures, as required.
- Conduct annual product reviews for Drug Products.
- Design and conduct training covering Pharmaceutical cGMPs and other regulatory requirements.
- Participate as an auditor in the GMP and internal audit programs
- Generate and analyze various quality metrics, as needed.
- Bachelor of Science or Master’s Degree (i.e. Engineering, Chemistry, Biology, etc.) with significant experience in quality assurance/control, operations, analytical or other technical functional area.
- Three to five years of experience working in QA in the pharmaceutical or related industry.
- Demonstrated proficiency in 21CFR 210 and 211 and ICH guidelines.
- Must possess excellent oral, written, and communication skills.
- Must possess strong computer skills with proven proficiency in Microsoft Office and experience with Electronic Documentation Systems.
If you describe yourself as an enthusiastic, highly motivated team player who wants to grow with us, we encourage you to apply! Please send your resume and cover letter to: firstname.lastname@example.org
COUR is a rapidly growing biotech company in the Chicagoland area that develops therapeutic products based on our deep knowledge of immunology and material science. Our team combines the skills and experience of biologists, material scientists, chemists, and engineers. COUR is expanding its laboratory and manufacturing capabilities at the Illinois Science + Technology Park, located at 8045 North Lamon in Skokie, Illinois. COUR is an Equal Opportunity Employer.