Job DescriptionThe Quality Assurance (QA) Specialist conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment; and with a team to implement inspection plans, quality plans, support auditing functions, and/or evaluate supplier performance. Contributes to the planning, implementation, and administration of cost effective Quality Programs, assuring that a system is in place which will meet contractual quality requirements. The QA Specialist will ensure the quality assurance of clinical manufacturing for quality standards of final cell products and identifies and assesses quality risk in activities and processes per regulatory guidelines, cGMPs, and standard operating procedures. Responsible for ensuring compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the cGMP facilities of the CBC. All aspects of systematic monitoring and evaluation of the various activities being performed in the cGMP cell manufacturing that appropriate standards of quality are attained and to assure that products are required quality for their intended use.
Primary Duties and Responsibilities:- Assists in the second-level QA subject matter expert/enforcement review of processes in compliance with quality procedures; overall objective of review for investigation.
- Measures and evaluates supplier quality and delivery performance; maintains supplier quality record files; maintains supplier approval status.
- Collects and reviews defect data contained in non-conformance forms, summarized defect data and publishes trend charts and corrective action status and effectiveness.
- Assists with document control and records management.
- Serves as a SME on the use of risk-based tools for qualification, training, monitoring and disqualification.
- Assesses and approve any changes to cGMP-systems to assure validated state of the systems is maintained.
- Creates and or maintain standardized templates for documents, forms, and similar to provide consistent finished product.
- Point of contact for Processing Change Orders (CO).
QualificationsEducation:- Bachelor's Degree in molecular biology, biochemistry or related science/engineering field is required.
Experience and Skills:- Three (3) years of experience in Quality or Regulatory compliance is required. Five (5) years is preferred.
- Ability to apply critical thinking to analyze and interpret information and/or data.
- Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
- Ability to provide and/or support a level of work excellence and accuracy; recognize and address flaws or errors that others may overlook.
- Ability to apply advanced knowledge of science/learning/specialized intellectual instruction to analyze, interpret or make deductions from varying facts or circumstances.
- Ability to develop and deliver effective presentations.
- Ability to operate mechanical/medical devices and/or equipment.
- Ability to handle multiple demands and/or manage complex and competing priorities.
- Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
