Quality Assurance Specialist
Company: Cour Pharmaceuticals Development Company, Inc.
Posted on: September 22, 2022
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
* 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
* 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
Education, Qualifications and Experiences:
* 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
* 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
* 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
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
Keywords: Cour Pharmaceuticals Development Company, Inc., Skokie , Quality Assurance Specialist, Other , Skokie, Illinois
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