Clinical Quality Assurance Specialist

QUALIFICATIONS:

Education and Experience:
Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

KNOWLEDGE, SKILLS AND ABILITIES:

• Thorough knowledge of applicable GxP and appropriate regional regulations • Firm knowledge of the clinical trial process

• Good knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Effectively works independently or in a team environment
• Effective problem solving skills
• Solid organizational and time management skills including ability to multitask and prioritize competing demands/work load
• Strong computer skills; ability to learn and become proficient with appropriate software
• Proven flexibility and adaptability
• Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.

SUMMARIZED PURPOSE:

Provides basic level of expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). Will attend inter-departmental meetings related to the area of expertise and provide input. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of expertise.

ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION:

• Serves as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management.
• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions.
• Provides training for department and/or laboratory staff where required.
• Reviews batch records and associated documentation for completeness and accuracy of data.
• Utilizes department checklists to evaluate content of reports and compliance with reporting criteria.
• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.
• Handles production pre and post line clearances and in-process checks as per GMP requirements.
• Provides support to the department with incoming material inspection as per GMP requirements.
• Participates in risk assessments.
• Manages set up and filing of documents.
• May mentor junior team members in area(s) of expertise.