Onsite Clinical QA Lead – GCP & Regulatory Compliance

Bering-Alaka`ina Holdings, LLC; Silver Spring (MD); Vor Ort; USD 129.000 - 133.000; Vollzeit

Benefits dieser Stelle

401K with company match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Tuition reimbursement

Paid time off

11 paid holidays

Zusammenfassung

Alaka`ina Foundation Family of Companies is seeking a Quality Assurance Officer to support a government customer on site in Silver Spring, Maryland. You will oversee onsite QA activities, conduct audits, ensure regulatory compliance (ICH/GCP) and maintain SOPs while training staff. The role requires 5+ years in clinical trial QA, an associate degree (bachelor's preferred) and a background in quality management.

U.S. citizenship and ability to pass a NACI are required.

Qualifikationen

• Associate's degree required; four+ years experience in QA for clinical trials.
• Bachelor's degree preferred; certification in quality management preferred (ASQ or equivalent).
• Minimum of five years of experience in quality assurance for clinical trials with expertise in ICH/GCP compliance.

Aufgaben

• Responsible for Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities.
• Conducts audits and reviews/analyzes data and documentation, including internal audits such as the laboratory.
• Develops and maintains SOPs; ensures Human Subjects’ Protection, FDA, and GCP regulatory compliance; trains staff.
• Facilitates QA monitoring by study sponsors.
• Plans and accomplishes goals and tasks using experience and judgment; may lead others.
• Prepares and maintains instructions and guidelines for job functions.
• Coordinates with Clinical Trials Center to ensure study-wide compliance.
• Ensures completion of internal/external audits; assists CRC with regulatory compliance; maintains staff credentials; quality control of source documents.
• Prepares monthly status reports and may lead the team.
• Performs other duties as assigned.

Kenntnisse

Quality assurance

Regulatory compliance

Audits

GCP/ICH

Documentation review

Team leadership

Ausbildung

Associate's degree

Bachelor's degree preferred

ASQ certification preferred

Jobbeschreibung

Alaka`ina Foundation Family of Companies is seeking a Quality Assurance Officer to support a government customer on site in Silver Spring, Maryland. You will oversee onsite QA activities, conduct audits, ensure regulatory compliance (ICH/GCP) and maintain SOPs while training staff. The role requires 5+ years in clinical trial QA, an associate degree (bachelor's preferred) and a background in quality management.

U.S. citizenship and ability to pass a NACI are required.