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 the manufacturing process, quality systems and finished products comply with cGMPs and all applicable government, customer, and company expectations for quality and safety. Responsible for leading quality assurance programs including Annual Product Review, Batch Record Review, Deviation/OOS Investigation, Stability, and Validation, as well as working closely with and supporting Quality Control on lab investigations, method development and qualification, and Operations on facility management and manufacturing.
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
- Compile and approve summaries of Product Out of Specification (OOS) Investigations. Implement any corrective actions needed following any deficiencies found during batch record review, OOS/deviation investigation and mock audit exercises.
- 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/systems remain in a validated state
- Conduct annual product reviews for Drug Products
- Coordinate stability studies
- Design and conduct training covering Pharmaceutical cGMPs and other regulatory requirements.
- Participate as an auditor in the GMP and internal audit programs
- Assist the deviation investigation program and ensure compliance with the quality management and regulatory requirements.
- Generate and analyze various quality metrics as needed
- Assist in various quality activities as required
- Contribute to building out a world-class quality assurance organization
- Bachelor of Science or Master’s Degree (i.e. Engineering, Chemistry, Biology, etc.) or significant experience in quality assurance/control, operations, analytical or other technical functional area.
- Three to five years experience working in QA with pharmaceutical ingredients or products.
- Experience with 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 Word, Excel, Power Point, Visio, and flowcharting software. Experience with Electronic Documentation Systems is a plus.
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: email@example.com
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.