Quality Assurance Associate
Job Description
Job Title | Quality Assurance Associate |
Reports to | CEO |
Department | Clinical Trials |
Location | Remote |
Supervises | None |
Job Type | On Contract |
Company Overview
Credevo is a consulting company that supports organizations in their business development and assists healthcare companies with their product development, from clinical development to commercialization. Credevo provides strategic support in areas such as regulatory, clinical development, licensing (out-/in-), and feasibility support, for products including pharmaceuticals, biologics, nutraceuticals, and medical devices.
Job Summary:
The Quality Assurance Associate plays a vital role in ensuring adherence to Good Clinical
Practice (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and
company policies in clinical trials. This position is responsible for supporting QA processes,
conducting audits, and assisting in risk management to uphold high-quality standards in clinical
research.
Key Responsibilities:
Quality Process Maintenance & Improvement:
● Maintain and enhance quality processes to ensure compliance with GMP, GDP, and
GCP standards.
● Collaborate with cross-functional teams to manage change controls, CAPA, deviations,
complaints, and internal audit follow-ups.
● Investigate GxP non-compliances and customer product quality complaints.
● Utilize quality tools and techniques to perform root cause investigations and resolve
quality issues.
Compliance & Documentation:
● Develop and implement corrective and preventive action (CAPA) plans to address
non-conformances.
● Update, maintain, and improve QMS process documents.
Perform data analysis, prepare quality trend reports, and communicate insights to
internal stakeholders.
● Oversee product specification creation and control.
● Conduct Product Quality Reviews (PQRs) as required.
Regulatory & Quality Assurance:
● Ensure regulatory compliance in distribution supply chain operations for commercial drug
products.
● Support GMP/GDP service providers in maintaining post-approval compliance.
● Implement Standard Operating Procedures (SOPs) and oversee their adherence.
● Provide QA support to pharmacovigilance and regulatory departments.
Skills & Competencies:
Essential:
● Strong knowledge of GMP and GDP operational quality systems.
● Experience in pharmaceutical or life sciences organizations.
● Familiarity with quality system processes (e.g., Audits, Deviations, CAPA, Change
Control).
● Strong experience in writing, implementing, and maintaining SOPs & quality documents.
● Ability to analyze, research, and report independently across diverse topics.
● Excellent organizational and communication skills.
● Strong attention to detail and ability to work under pressure.
● Ability to work autonomously and prioritize tasks effectively.
● Flexible and adaptable to changing business needs.
Desirable:
● Experience managing communications projects (graphics, online, video, etc.) and
working with creative contractors.
● Native or fluent English proficiency
● Degree in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Life Sciences,
Chemistry, or related fields).
● An inquisitive mindset with a proactive approach to problem-solving and continuous
improvement.
IMPORTANT: You will need to login to your gmail / google account for authentication to apply.