We seek a motivated Quality Assurance (QA) Specialist to join our rapidly growing and dynamic team. PolarityBio is a clinical-stage biopharmaceutical company located in Salt Lake City, Utah with the goal of developing first-in-class skin regenerative products.
The QA Specialist will be responsible for performing quality review 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. Responsibilities include Annual Product Review, Deviation/OOS Investigation, Material Release, 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:
- Assist the deviation investigation program and ensure compliance with the quality management and regulatory requirements
- Participate in designing and conducting training covering Pharmaceutical cGMPs and other regulatory requirements
- Perform quality activities during the manufacturing of drug product batches
- Implement any corrective actions needed following any deficiencies found during batch record review, OOS/deviation investigation and mock audit exercises
- Validation (lab, process, and method), qualification (DQ/IQ/OQ/PQ) and requalification activities
- Participate in annual product reviews for Drug Products
- Assist in the Material Release and Supplier Qualification process
- Participate as an auditor in the GMP and internal audit programs
- Perform Audit Trail Reviews
- 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
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 functional area.
- Preferably 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:
PolarityBio is an Equal Opportunity Employer.