QA Specialist
Pharmaron

We are looking for a QA Specialist to join our team in Baltimore, MD. This is an on-site position. You will be responsible for ensuring that the clinical operations department functions in compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and SOPs.

Day-to-Day Functions

• Maintain a high level of knowledge and understanding of the Federal Codes of Regulations and Good Clinical Practice Guidelines (GCPs).
• Participate in developing, maintaining, and improving the Pharmaron CPC Quality Systems.

Procedures

• Ensure all Standard Operating Procedures (SOPs), Policies, and Work Instructions for the Clinical Operations department are reviewed annually and updated as needed for agreement with current practices and industry standards.

Internal Audits

• Perform protocol-specific internal quality assurance audits (i.e., source data, ICF, dosing, etc.),
• Conduct process audits of the Clinical Operations department.
• Prepare audit notifications, plans, agenda, and final audit reports.
• Clearly communicate and report (verbally and in writing) audit outcomes to Quality Assurance Manager.

Regulatory Inspections and Sponsor QA Audits

• Assist the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections.

Quality Control

• Ensure initial IRB approval (i.e., protocol, ICF, recruitment material, participant material, etc.) is received prior initiation any study related procedures.
• Ensure IRB approval of all Clarification letters and Protocol Amendments are received prior to initiating any new study related procedures.
• Ensure the following are performed:
  • a quality control review of all source documents is completed prior to use of the documents.
  • a quality control review of all primary tube labels is performed prior to affixing each label to the primary tubes.

Staff Training

• Ensures all clinical staff members completed protocol-specific training on all versions of the protocol.
• Confirm clinical staff members, complete initial and refresher annual SOP training as well as regulatory compliance training.
• Confirm clinical operations department are trained on clinical equipment, clinical skills, good documentation practices and quality control review procedures.
• Ensure all staff members sign and date the delegation of authority log prior to performing any study related procedures.
• Equipment
• Ensure preventive maintenance inspections are performed on all clinical equipment according to the manufacture recommendations, prior to use.

Non-Compliance

• Ensure all protocol-specific deviations are documented on the designated protocol deviation log and when applicable reported to the Regulatory department for submission to the IRB.
• Prepare and track all Corrective Action Preventive Action (CAPA) Plans within the Clinical Operations Department.

Education and Experience

• Bachelor's degree in a scientific or health-related field.
• At least 2 to 3 years of experience in management of quality assurance in a clinical research setting.
• Strong knowledge of GCP, FDA regulations, and ICH guidelines.
• Excellent time management skills and must be able to prioritize workload.
• Attention to detail to ensure accuracy of data and adherence to protocol requirements.
• Exceptional verbal and written communication skills.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to identify and communicate risks.

This job has expired.