Quality Assurance Specialist
Company: Cour Pharmaceuticals Development Company, Inc.
Location: Skokie
Posted on: August 5, 2022
Job Description:
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: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
organizationEducation, 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
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:
-info@courpharma.comCOUR -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.
Keywords: Cour Pharmaceuticals Development Company, Inc., Skokie , Quality Assurance Specialist, Other , Skokie, Illinois
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